Earnings call transcript Q1 2023

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Good day and thank you for standing by. Welcome to Aclaris Therapeutics First Quarter 2023 Conference Call. At this time, all participants are in a listen-only mode. [Operator Instructions] Please be advised that today's conference is being recorded.

I would now like to hand the conference over to your speaker today, Robert Doody, Head of Investor Relations. ahead. go Please

Robert Doody

and am Aclaris. I a Head Investor financial of release Thank note Robert that for results XXXX quarter Please our issued business earlier Relations matters. highlighting you. first Doody, other today, press we

have of the it, under you yet those website page releases of the For section not release www.aclaristx.com. of find our press seen who you posted press will the Investors

found call, to on as slide In Investor addition, deck a this which we can filed investor XXXX an X-K morning. to our be will of earlier we entitled conference the furnished page the corporate our be QX and SEC with that referring website Form exhibit

Officer; Kevin Doug Financial our call Joining me Officer; the Balthaser,, Officer. today Chief Chief Manion, for Scientific Officer; Monahan, our Joe our Chief Chief and Gail are Medical Executive Cawkwell, our

I we strategy within Aclaris' about this like are statements would the to prepared remind company's during considered federal laws. future and meaning the position, our future operations Before that make objectives securities call forward-looking for statements plans of and financial begin we remarks, operations, various of you and results business

actual from assumptions upon forward-looking changes to circumstances, Our that could and results those materially cause involve uncertainties based expectations differ reflected in in that statements. risks, statements current are such

described Aclaris' These time. SEC section of and filings to Investors Aclaris other available are section website of the year XXXX XXst, from page www.aclaristx.com. Aclaris' are Risk time filings risks in These Factors the under the makes the December Form the XX-K of ended for documents SEC the with

of webcast. or events page the link to under investor and website. can A any is statements this information, section that recorded the of our be today be this conference obligation we on may the is and to call Events of call information account on accessed the of as no otherwise. on webcast we new provided the provide All advised being make we undertake forward-looking today's update future call Please

Doug. the now turn to call over I'll

Douglas Manion

my Thanks, but to only Bob. speaking had for you you is quarter with also distinct honor I team. CEO, weekend. It quarter leadership not first new the everyone. Good operations be of as following morning, our hope my first a great today,

may as who were Confluence predecessors years that specialty focused Therapeutics on pharma newer Aclaris my conditions. few based story, made in a to to those Saint we to acquire the originally For great Louis. the ago Sciences the decision a be dermatologic company It is founded credit a Life company

pivot efforts human agents. research this The Aclaris addition areas tissue to in the focus unmet of with group need allowed oral on or immune-inflammatory of its and on diseases specific world focused genome, class development discovery towards addressing serious

transactions Prometheus. As the of program acquisition evidenced a TYKX the INI Arena, space, recent in Nimbus number by of of acquisition Takeda's of Pfizer's acquisition Merck's and including significant

There our MKX and find creation is in value led inhibitors diseases of opportunity assets by ourselves potential for ATI-XXX. clinical tremendous of targeting we the significant or shareholder in having these stage potential this position key several zunsemetinib first-in-class space, enviable

in three well to the plans quarter the presentation, and of overview an today. the pleased of provide for speaking for call If agenda slide first our be your of results, slide today very timing an you the direct can could to to financial with our we our year. as update you attention discuss We're as remainder

all updates date remarks across and performance who over begin call the the on the few clinical of the programs. to we'll provide for then on company's to will opening development progress our a I'll providing by Gail, year, turn

or trial in HS, final results hidradenitis we the suppurativa back and an March. Following in will that results update, line reported provide the Gail which Joe of for top overview from

closing some for our company provide the of to of pleased I'll overview comments prior performance the address the quarter an your through up then results first very Overall, financial our questions. with And opening I'm will to this Kevin provide of period. call finally, XXXX.

development of is which are team and company testament we our Our our as team a is advancing small of tremendous making a all size relatively to various in programs, progress, clinical terms overhead.

remain their also choked global economic to ability continually team's to trials clinical I continue conflicts. impressed chains in is taxed macro environment by and execute a challenging Despite with downturn, global that supply face all of continuing And that, not these more studies be they creativity arise. flexibility in to these is prosecute and our for I hurdles team headwinds, could demonstrating and when proud. the

of the results our and top reported Phase first year, of the quarter completed in trial we Xa line ATI-XXX HS. During this

were disappointed were and for we our in a time still Although relatively hoped on delivered had disease, not that misunderstood challenging trial. results we the team what well-executed efficacy this

this from further ATI-XXX. and experience The this study of Importantly, and foundation trial a the program both demonstrated our understanding further for completion pharmacodynamic perspective. has expanded the of safety

arthritis. Going rheumatoid in into our data psoriatic next arthritis and readouts

array reminder, proof-of-concept more final of execution a rest the of prior Xa in continued our and program. focus trial, providing the a Gail be the already a from with how of Shortly, will on had our positive on inform Joe company data the As trial. results ATI-XXX details Phase they

discussion to With Gail? that, I'm over to on the Gail clinical now development going to call the turn begin progress.

Gail Cawkwell

trial, their I moment team study, enabling hidradenitis they've us on fully to work morning, want to execution today's Doug, the recent on to you also everybody. of also a analyze and to the all the commend weeks from you, the thus the Thank but suppurativa done of tremendous with Aclaris in provide results take good overview.

of Directing our pipeline. you four, slide summary to the development

progress dose the asset multiple the on ascending X in Phase ATI-XXXX Building to ascending our ATI-XXXX study. study and with dose volunteers well. healthy start continues single of The successes ITK/JAKX inhibitor. clinical stage Let's

and year. second are We on very track have this the in pharmacokinetics, pharmacodynamics much to half of safety results

is announced, previously be to first a population we clinical Xa in patient in ATI-XXXX of study a colitis. As proof-of-concept our ulcerative Phase trial planned

X dose of a of quickly to the in you study. with this results completion provide ulcerative after can that Phase more details Later study. study we fully colitis will and be year, initiate we ascending is the well have position this design finalized upon planning on we proof-of-concept the The multiple ongoing underway so have the

to MKX academic our on of setting next-generation ATI-XXXX, in breast prospective Moving and objective in closer moving to with ATI-XXXX ultimate cancer partners cancer. into metastatic inhibitor, our the get pancreatic we're

Now shifting to slide six.

our in exposure, ATI-XXXX, was JAKX/X follow-up and for Phase systemic designed For topical inhibitor, dermatitis a our a minimize study. Phase are which as Xb atopic skin to conducting Xa efficacy successful we study

limited are The Xa Phase further and efficacy seen exposure the evaluate validate objectives of the safety trial and ATI-XXXX the the systemic in to of study.

which the X% regimen lower several studied well that twice dose trial in once several strains and Phase will are formulation and the development. daily Phase We progressing best Xa for twice-daily also dose we studying X including dose as be so into assessing strains, applications know as

a children Index patients. XX, of meaningful with We from been primary therapies also The the children. is other target given this of the medical at to week percentage array and Severity and four. of include baseline Eczema expanded or recently endpoint The age Area We've (EASI) in score our to importance disease the population some study down need in in change the the the topical enrollment very study milder in seen by XXX is in broader success trial patients encouraged patients.

want in mild past conducting is this in not and As protocol winter patients assure evaluate season eastern protocol meaningfully patients of as other some from such, enroll severe because atopic locations, dermatitis, many important This we encountered the you may And portions enrollment some mild we driven we in companies of winter well. some southern recently trials the have dermatitis, US. challenges, them. adequate particularly just particularly seen modification the but reported to include as to moderate have and extended by atopic to the mild can also

associated few amendment, atopic In dryness the cold we Since weather which just heating in meaningful effect winter into protocol can have and increase weeks already went a first of with the seen dermatitis. screening. exacerbate this

are terms that half we to guidance learn guidance results and in prior the move of about protocol. to our as amended year, we line We will continue of of our updating top from of the to up midyear tighten impact timing this of second more guidance

seven. slide to Moving

statistically efficacy and trends of itch, secondary percent primary analysis by positive our and a of ATI-XXXX of area reminder, improvements achieved IGA modified EASI-XX in reduction including As body results in in endpoints, Phase impacted at four, the week significant observed responder were endpoint trial, surface disease. Xa responders, the

Shifting to eight. slide

have of ATI-XXXX JAKX/X, patients Importantly, than a the low to never safety seen of patients ICXX ATI-XXXX because was average with observed of the topical following X/XX soft in greater greater levels the and plasma profile and the had than application approach, three the tolerability X% of topical ICXX. only of concentrations were concentrations favorable very and

more a of with trial full set. that have we onto Now HS We'll begin moving ATI-XXX. the overview the comprehensive data now

not know reported our either all in endpoints or top that results HS. in ATI-XXX the from you did As fit line we March, secondary primary efficacy

As placebo on the the treatment. placebo slide patients arm the and randomized complete ATI-XXX. patients XX on XX we shown active on on into and XX, with with study Overall, XX XX study XX on

the As which unusually buckets, These trial our demonstrate can efficacy by on overall. the previously ATI-XXX of pharmacodynamics. from be into noted, today will modest fall ATI-XXX was applied detail the discuss spend safety this for HS. the study the overshadowed pharmacodynamics. Joe then elements want of safety did in to in and not majority will two large to that I saw time and do effect. an effect, of I elements understanding primarily placebo a elements discuss our We the treatment

steady the Slide baseline XX shows characteristics. demographics and

very From a serious on slide infections. with had organ patient and We we trial no toxicities safety of enrolled XX, serious no that opportunistic on perspective, more or proud inclusion representative we HS people. underrepresented was historically are events quite adverse ATI-XXX, of that no real-world end a serious populations

arm a What from we discontinued early have the starting given shown high enrollment slide early was from And patients in placebo this increase is of did XX. saw active we discontinuation of Difficulty] trial meaningful made Overall, treatment decision the reason of the efficacy the on treatment. we fall. and observation number arm the and unsurprisingly, XX [Technical the to see, discontinuations the study in last days we lack primary

to discontinuations loss of adverse and arm four balanced the XX due between the ATI-XXX and investigator the relatively with an and withdrawings noted event, arm. of efficacy The for divergence lack to from stated follow-up, in and were arms. placebo-treated due withdrawals placebo the ATI-XXX Withdrawals to withdrawal was consent,

however, than no active study. to at AN bit XX not treatment-related the the a deeper, seeing we talk seven event, count majority efficacy. Their noted patients either of worse or the due was the the we better of that arm of were withdrew adverse who in start When an

not are events the to who adverse continue a intensity, it discontinuation seeing to not treatment benefit in of of had moderate a incentive that most surprising treatment. only While leading little were is patients

Further, which or most discontinuation closely like new events subcutaneous growing that worsening worsening HS HS. to to is the related acne, to adverse led were commonly abscess related abscess,

a when typically resolves also investigator investigators in arthritis continue for the known topic, phenomenon no to which some course, We discontinuations the further this saw trials. few of with period is we treatment in and occurs arthritis a this we had this also withdraw subjects dizziness, headache ongoing And rheumatoid due patients further or psoriatic early education to And reason. and that provided treatment. even patients on for education

quite the important to we process, in trial. when our into seeing are stage trial and initiated and arthritis we that an to well current the model advanced discontinuation enrollment of trial, a our we is rheumatoid below rate our projections It's pertaining stable note are

let's which the CK, or from attention captured to is elevations shown line the Now that creatine in on on topic results, XX. other slide phosphokinase move top

we the learned brings of patients CK had was study one we percentage release, such, that that reported five or data, reported. XX.X% patient to below drug, that has prior CK category, as were so event. these receiving elevated not we threshold noted our press XX% down elevated the been level. this which adverse our that Subsequent top issued we treatment-emergent we finalized line, had And from treatment-emergent blood a their patients removed to there of that When events as that

X during covered CK and of patients both some patients elevations elevations, majority with study. reported were you and drug, were in the also however, we on ATI-XXX Overall, placebo these modest of Grade two The placebo in CK ATI-XXX. drawers as Grade were on X, elevations Grade CK point Six with three on though, these on had see XX and study elevation. laboratory levels can one XX X on in of

even transient and most moving patients and when most typically to However, were the treatment-emergent elevations where typically to return XX, CK baseline that Grade treatment. continued slide X above on

of history them a were with Many exercise. associated of

were associated were associated more something with. is events There elevations was no severe would More on. not suggest adverse going that CK importantly what the

were example, We skeletal CK inhibitors For that muscle have no with abnormalities not CK do effective kidney from the inhibitors. weakness, or like benign know TNF been that and treatments pain, other elevations reported elevations seen source. muscle anti-inflammatory JAK

Overall current The transient CK profile slide see do meaningful or kidney patients elevations or XX. We've development. serious in symptoms. be seen stage cytopenias that not very we seen safety with and the continued profile muscle-related to to We've no Moving to no with the event are we effects expected. through and adverse as have disappear opportunistic some any or generally on treatment infections. with has ATI-XXX clinical pleased continued of date, liver

have in and are no now identified. chronic to Lastly, issues concern note the completed we of all it there is with our pathology of X, preparation results for studies Phase toxicology available, important that

I'd to pharmacodynamic that over Joe? HS call to the turn pharmacokinetic to discuss study. from findings With the the like Joe and

Joseph Monahan

Gail. Thanks, Good morning, everyone.

start ATI-XXX chance study. me had saying a the the outset, mechanistically believe demonstrating in that of efficacy HS Let we by at

more likely believe that perhaps than is systemic pathways. through the it is skin we in disease locally However, the driven

Phase I from with pharmacokinetic Xa peak across dosing study. PK the would and week analysis. have to drug for behaved expected share trough levels to the a first in Phase accumulation RA pharmacodynamic similar learned like as modest study now HS the MAD observed what we those and Briefly, the of ATI-XXX and and X the study

For took on ATI-XXX in shown two blood, understand to we HS slide as XX. pharmacodynamics PD, approaches patient

First, compared patients donor two parallel. samples in an analyzed on from and HS vivo subset blood in healthy both cytokines sample ATI-XXX five sites. with we from ex of conducted analysis small stimulated treated patient patients placebo a We controls of

after first TNF IL-X again and IL-X We dose the beta, the looked four pro-inflammatory at alpha, then cytokines, at study. end the IL-X and of

in can XX-week your side-by-side ATI-XXX TNF see while the inhibited study slide to HS study XX, and and the analyzed, Xa date. three studies seven-day the you shown study. volunteers, comparisons all direct focuses the attention of The you ATI-XXX of alpha four Phase If cytokines across IL-X completed on beta. XX-week data to we MAD provide RA inhibition

either healthy here suggesting ATI-XXX. the is reprogramming is with dependence end similarly the of day production continued studies one, Also note proinflammatory three all near two patients ATI-XXX their that inflammatory at and or these seven and production cytokines consistent inhibition subjects across HS On these potently RA inhibits pathway is complete all and that the days cytokines important and weeks, on studies, MKX the of of pathway of on each cytokine observed to to MKX. patients in across lack taciphylaxis sensitive dosing period, of XX dependent

subjects confirmed at day analysis dosed in were consisted [Technical it analysis ATI-XXX points pre-dose on this We controls, of of at endogenous HS plasma the all second one healthy that donor where samples and patients Our evaluating was out time carried Difficulty] trough. with at evaluating impact cytokines on XX patients. along

slide see in lower that these If your at to can baseline RA Xa the with in a study attention HS which compared Phase inflammation XX, pro-inflammatory were systemic consistent endogenous Xa you cytokines plasma and turn the HS you patients. Phase of level lower study, appears with CRP

X Phase of studies, slide and and TNF provides of analyzing RA comparisons ATI-XXX beta. between HS IL-X endogenous The MIP-X plasma on levels impact next IL-X, the the alpha,

healthy decrease levels RA of levels observed near studies, similar HS to both in compared Phase in or patients in cytokine were a studies. levels pre-dose was in cytokines While patients below donor the lower Xa persistent to

studies is and slide is a in both and anti-inflammatory receptor inhibited These evaluating IL-X to by plasma the ATI-XXX. endogenous XX, study either patients. the comparison in HS of and attention elevated can patients, modulation demonstrate see cytokines between which HS cytokine RA antagonist, your both selective pro-inflammatory both you Directing in data not RA

reduced which inhibition the CRP in shows attention of your completion RA in retained that study. at of HS the both This following Xa Xa systemic slide marker, Phase normal to similar like is levels plasma and to after of CRP days patients inhibition inflammation CRP the inhibition ATI-XXX studies. RA XX-weeks ATI-XXX in this and limit acute HS I observed upper the direct to would dosing, was seven were study XX, phase Lastly, to sustained of through treatment.

clear and summarize To cytokine the slide and results sustained pro-inflammatory blood cytokines stimulated inhibition MKX evidence three demonstrated of XX, on of response. ATI-XXX with ex of dependent marked in dependence vivo studies and durability whole consistent across inhibition

donors, saw relative elevated lesser RA observed less plasma extent blood other the In of HS HS as biomarker but to RA. to pharmacodynamic than of in suggests driven cytokines subset study, a healthy which such diseases endogenous that perhaps systemically analysis, we a than in terms the is

cytokines with of proinflammatory below were and RA The healthy cytokine similar ATI-XXX RA trends not a anti-inflammatory Xa in pro-inflammatory levels HS Phase inhibition in modulated IL-X either near ATI-XXX both or elevated reducing by effect. specific studies, suggestive was cytokine, study donor levels. two

phase systemic the inhibitors. pXX patients inhibition in acute RA in studies demonstrated observed the CRP The and both administered persistent inflammation global ATI-XXX effect contrast previously HS with to marker

with HS These completed systemic consistent data RA demonstrating efficacy to our on however, positive both and similar trial, RA and we readouts are effect from a correspond believe anti-inflammatory patients, not ATI-XXX HS.

Gail. to over back it turn I'll

Gail Cawkwell

Joe. Thanks,

you Xb Before the terms over to like the our everything with the later know pleased we very on is to in stages in that I I'm for up turn arthritis clinical much Phase program. Kevin let and ATI-XXX call touch the rheumatoid finish trial, are enrollment to I'd on financials, to of track.

international this quarter trial XXX-patient line in to of have results expect this year. the from We top fourth

safety not date committee regularly raised from we trial. related to noting have committee monitoring safety and also any an that that It is has meets issues independent data that worth this to

on arthritis numerous the arthritis dependent Phase heavily to running on touching recruitment Polish This last Xa the be our sites. trial a Lastly, rheumatoid trial. HS it started, also was the XXX Since also trials clinical this and is in psoriatic going study of the get to behind was bit trials. trial

Based took activations. on the than for surrounding of it longer some region bit anticipated the tensions a site little Ukraine, in

of first good for the towards we've enrollment the result, as guidance our we XXXX momentum this enrollment from This results and complete recently assumes into end sites. trial our the seen end this a However, of And screening we XXXX. adjusting from are of line Polish fully top half year. of in

despite of very professionalism the with well Overall, various you. to physicians the various our forward I and partners am reporting the hurdles, as all pleased as many of commitment development our team sites and look trial patients. I of so results to and

call Let to turn first discuss me over the results. our now to quarter Kevin

Kevin Balthaser

Thank morning, and you, good Gail, everyone.

highlights slide projected are financial XX. Our on

securities Let compared of us begin and equivalents with million, ended to cash with cash, $XXX position. marketable at $XXX our year-end. which We million QX cash was

our of funds transaction quarter, results. closed the QX end million. for million in will Additionally, This near our of $XX.X of X.X after first aggregate facility the sold so net of be close those the as we shares proceeds April quarter ATM part under second recognized

does ATI-XXX. associated to of funds, costs current our addition XXXX. like with the conducting do to fund cash cash, the note runway and those to will a securities continue the not cash equivalents our through we program Phase be X end operations of development our contemplate projection that marketable for We With that sufficient believe

year's quarter, to first advancement ongoing of driven primarily for XXXX performance quarter This net $XX.X the compared the difference our by quarter financial is for the clinical of million first XXXX. million our during royalties the million was loss our $XX.X during Regarding of licensing programs. higher in to property million was $X.X This driven on Total first the revenue, compared was prior revenue quarter increase from XXXX. quarter. the earned intellectual $X.X primarily for of out-licensed by the quarter

$XX.X R&D expenses for quarter of first first year the million XXXX. were $XX.X the compared to in of this quarter million

ATI-XXXX driven ATI-XXXX. As advancements by and of the ATI-XXX, increase been previously mentioned, this has

million support compensation expenses due primarily versus increased our administrative were $X.X same increase million the to and during increased expenses General initiatives. XXXX. This during related in growing to of QX driven $X.X period development to headcount XXXX was

will closing Doug now back I the Doug? turn that, to over With call for remarks.

Douglas Manion

you, Joe Gail, for to Thanks comprehensive and overviews. Kevin, those

execution to few at pleased questions, the shift to addressing final of the your team we a here Before Aclaris. like comments. with and quality I'd make I'm our very call entire

quality biotech We're medicines of a size. significant blessed team very continues needs. The medical and a novel to our pharma addressing engine research to that atypical deliver potential for is have world-class company conference unique targets unmet large against

the and The of difficult ATI-XXX, labor very fruits the a ATI-XXXX come. include broad trials. optimistic had the knowing We're trials we in very of completion in clinical ATI-XXX data disease of with our reporting and on and already complete We're about ATI-XXXX, very along and We ATI-XXXX to at with more HS laser-focused eager ongoing that potential that psoriatic and to took report in RA shot results a RA timely hand. positive arthritis. now on current

planning The indications of continued and the INI those mechanism studies X in other Phase the exploration for MKX indications. for

in continue next are a also and gratifying top-tier exception. these recently. no programs to is taken that on increased their very we execute fiscally or quarters have several see in investors several to exciting and Aclaris, stock our conservative are These the positions for either times manner. It prudent Importantly,

front of the we team apprising as in right in look work have of of lot our you a progress forward and continue us, forward. we but to have we We to execute, place

like Operator, the for now open to we line would questions.

Operator

Louise Chen with Cantor. Thank comes you. question the [Operator Instructions] from of line our And first

is line Your open. now

Louise Chen

on quarter for Congratulations taking question. the and Hi. progress this my all thanks

to that how think And to And the wanted of you the to read-through a of level, are second have HS people RA wanted I'm study? at results this then your the enrollment. in see year. that of might season? And you. dermatitis well question from did winter with study you what patients, market anticipating And really the evolving? UC, if proof-of-concept move I to So or and think in choose will on end do last drug RA the was milder the milder quickly you any patients first just you have lot is wondering into rapidly that to the can more atopic ask question kind from indication? And efficacy I do you did seen as how if do that first you come you how this this your population? that patient on of since drugs ask about you And is being in CK how elevated on just available get Thank to you

Douglas Manion

here. Doug it's Louise, Thanks,

RA, So but regarding focusing HS read-through the positive. from not to on CPK, and nothing we see

more we I as drugs, and have dozens drug one So safety real is profile have is. flags. significantly looking there's confidence the no that in really and of one red luxury of a this developed the it's to

Phase the complete works to would have the tracking -- safety to have competitive thought to so systemically exactly as as in in But we we and as RA far, we And did and profile. think an be attractive HS extremely Xa. it drug it's the Obviously, program. it

study going what bullish means very quarter of all this read in the of out that's in terms fourth RA of that we're to So terms the year. in

to elaborating up most your practice, even elevations regular CPK in level clinically overall mean a job follow kind based be would we and CPK, mean, Regarding in I we did but see Gail -- just just of think the didn't did I of cognizant, study, go on great they and what need are exercise, people of I down activity. of clinical irrelevant. these and not

saw was it CK if, we been and muscle be elevations and looked of on weakness, which in concern or of cardiac there's we've origin, no muscle there The pain, with none it, any at many like symptoms of if fact, a associated patients, fractionation these CK-MB. was the looked would it

issue. not do that CPK we a we think have So

board we the As any a flags monitoring RA terms the raised red in study. the that's data overseeing not safety mentioned, prosecution of They've study. there's all at of

good I in shape. think So we're

live to part question. people other for ironic the enrollment had a we things little companies west atopic been experienced have. a the following who We've of very, lots space on snowy the we have the very that country of Moving dermatitis winter. the It's in same because and

the was doing mostly the think lines Xb of enrollment we criteria it certainly else we're mild enhance that a areas data. today. and time very of that we're and is Northeast study, and we do fact, done have We Southeast, study slowed Phase the moderate uptick The and the in we're in But expanding the that the is seeing U.S. in the was which to mild in We everybody in enrollment. AD terms to going Phase don't confident recruitment, to dermatitis. atopic issued terms the in Xa of severe winter,

some nice drug we'll ulcerative forward and going work That very in those effectively mild We UC. was year. have interesting to And the of in believe a then see in very and half is look this second patients regarding to for data a results deal the they and colitis. lastly, Merck Prometheus I think

diseases seeking ever there in indications that kind very cell because bunch ATI and in of subsequently, see kind in we'll the how a are the other market UC that T don't other think of But same the the folks area. attractive whole hunting is mechanistically evolves. my are towel you and throw of we're initially XXX looks experience We that

the Pfizer. look There's with in the awful if an But people you be think we at we're Arena very to and deal, Prometheus investing that going lot deal that and in space. of competitive IBD,

Louise Chen

Thank Okay. you.

Operator

our from Goldman with question. of moment One And our Jenkins the comes for next question Sachs. you. next Corinne line Thank

line Your now is open.

Corinne Jenkins

morning, Yeah, good everyone.

compare a to other further alluded how that the development to a prepared therapies and elevations you relative feedback the contextualize or oral CK KOLs approved on the are little could bit similar this indications, there? for including have received you but like any remarks, in the JAKs, You then And have I from TYKXs regarding And and what's TNF then sought alphas. tolerable follow-up.

Douglas Manion

Yeah, so me start. let

First, voice, Corinne. nice to hear your

the But So of of in space. investigators. lack of INI in has impact the and word, the better other for for is going a bit issue, nothingburger mechanisms of terms clinical our elaborate in CPK Gail a to a of trials CPK been

about. nothing and are asymptomatic elevations CPK that rheumatologists dermatologists to So really worry understand

but them, it's us Some why we're of to have so. even kind do it procedure standard asked that measuring is

do CPK concerns clinically we've Gail, mechanisms? significant that seen the finding. want about zero So clinicians other to is a this you with elaborate from elevations

Gail Cawkwell

Sure.

covered one recognize label concern is, not things necessarily a while So doesn't of the seem think at in to I safety all. the just to because be it

TNF arthritis, through disease, particularly inflammatory If juvenile particularly in in rheumatoid and the also you but JAK skin look bowel and inhibitors and arthritis diseases. literature,

what's you muscle regeneration muscle termed where as these showing inflammation. in to seems sort CK decrease and as bulk going elevations benign way up the You and improvement see of CK a be function been muscle of

basic JAK There's research on here. see of seen of be what element inhibitors that would pretty no to differentiation well we think, pathologic expect I going that as we of typical date is may And anything with happening. to what that's, science have really supports what and evidence been important some with an [indiscernible]

Corinne Jenkins

really then an cytokine didn't IL-XX, And respect just whether decisions. among IL-XX and with saw to And others qualitatively development just you on speak to show an inform profile you Thanks. and cytokine you're noted maybe that future comment the what IL-XX. but knockdowns of could seeing evaluation other emerging you endogenous can there

Douglas Manion

I'll let Joe take that.

Joseph Monahan

Yes.

With reduction resulted HS And patients of as and with that level in ATI-XXX two subset IL-XX mentioned, and IL-XX did endogenous a IL-XX the a where those cytokines well. was in ATI-XXX So in IL-XX. was reduction with was in IL-XX, a in the result in patients, of there was elevated. and measurable you elevated patients IL-XX,

a in was levels reduction those the measurable by those So in cytokines of both ATI-XXX. there

Corinne Jenkins

for Great. Thanks. that. Thanks Okay.

Joseph Monahan

Thanks, Corinne.

Operator

line please. One our of our Thomas for Securities. comes question the And next question, moment next SVB Smith with you. Thank from

now Your open. line is

Thomas Smith

have Do discontinuations the And questions. tremor. there CNS events, for Good you were guys the a study Thanks on to I sense signals? the the Hey, . for the CNS these though dizziness, first headache, and etiology can clarify events? morning. HS you if taking adverse guess, due any

Douglas Manion

Tom, Yes. Hey, Doug here.

So in at do animal drug crosses not studies, barrier. believe the we blood-brain least, our

if ramification. be a it But symptoms. I'll an enigma to is on such So bit speak little Gail any let of us, there'd

Gail Cawkwell

Yes.

even it or some that, to seen unit transient. signal throughout in saying by our not we've that a where studies they also and few unusual dizziness also we've weeks unit start because I'd the So monitoring We've careful cases, -- program. really days our very both seen in several have patients some seen in Phase those stay it be X headaches, of for but tends

when patients feel they've why rationale in So this been of real the there looking at way. this, cases, been for any may most hasn't

said, already including not unit crosses ATI-XXX seen and have Other very closely dizziness been the patients evidence our X pressure that studies, monitored changes in might CNS. those were things really those any of where we in into Phase have Doug blood that As don't cause in settings. headache like

going that is something it's news patients are I think resolve to treatment. and occur the we be to to is that found what may know the good stay patients likely is when willing on

Thomas Smith

how Like half provided color Understood. And helpful. RA if the that rate? you on provide about it relative discontinuation that right? you then discontinuation, X/X? the HS Okay. elaborate discontinuation or on to study, or exact you on you at can roughly can't rate? all? we some in That's the number, Is line should just Can think maybe And an it characterize

Douglas Manion

Yes.

can't studies. Phase study, It's below rates suffice seen competitive power Phase or Xb say, a but we and at the based X on calculations been So in precedent elaborate. that our discontinuation it studies, have blinded we're and we tracking to

Gail Cawkwell

And just over to has rate that I'd only very been stable that, time. add

Douglas Manion

you. Thank

Thomas Smith

Great. taking it. Okay. Thanks guys. it. Got question, for the Appreciate

Douglas Manion

Thanks, Tom.

Operator

question. for the Thompson from line question And our Thank you. of will our come One Alex next next Stifel. with moment

Your line open. is now

Alexander Thompson

my Hey, taking thanks for question.

the events CK where table four sort in treatment in Just elevation. sort one I what terms fit of if one emergent of that grade you more was if wonder quick XX and on slide adverse Joe on could the you're comment on this the as and maybe kind prior seeing target study in and what and of a studies PK bit on comment observed little then well the elevation Thanks. coverage could there. CK if of consistency

Douglas Manion

Yes.

let So start. me

run [indiscernible] people, studies. asymptomatic So that me it's a and will of that to event. clinician as always to event some laboratory strange investigators It's choose adverse off some adverse tick always clinical lots clinical

just the why they events. to were those by as elevations explanation elevations. events as let elaborate them CPK not happen such, an have luck where to four of toggled magnitude were don't placebo, the there really in of we patients have Gail regarding I'll be on so And adverse

Gail Cawkwell

deck in the is best can slide in I what the XX say at your right. on looking And graph Yes. our

can treatment CK And adverse in treatment-emergent highest elevation a you saw considered one ones in being we baseline was it originally That CK bright was at elevation longer not almost no event notice didn't not treatment have happen we on blue that emergent. one at occurred on because You'll our one occur all. that there the which of reported that did is and see that treatment study. the was

a It increase we The that had history patient and second it again, whatsoever. the highest in elevations And symptoms both down no grade these down. it next in. by had is CK, is follow-up one. of higher And and was already was to yellow she that lab, back this exercise single study, entirely a when in were normal. saw And when came back on the came

course, that CK graphic blue as the are right the to, elevations emergent. one, reported out to these were not So which excluding events adverse of that turned in be treatment

that I before can in higher of you moderate -- terms of there elevations. where in CK CK was patient of than at And one to But the of the range higher toxicity there's enough, on grade interestingly no treatment purple, a see elevation elevation treatment. just think course, there's then,

of So that grade zero was considered change. sort a

Douglas Manion

the to for PK the with And study. question about address PD the target and

seeing the that. than TNF study we day to greater and production, milligram at look inhibition XX% we if alpha demonstrated of pharmacokinetics targeted had at XX that HS than at inhibition than I in think some XX, we're XX on greater So greater IL-X you're the trough. you have the dose the beta. at PD XX% data the generate that seeing of And percent inhibition at of ex-vivo And trough cytokine peak, and

we So I that. think achieved

Joseph Monahan

so the any to these toxicology drug. we -- just had see see run are on date. have to in monitor today. you we humans that in XX They transient. that We zero the And that symptomatic go in toxicity away elevation didn't of program, close CK muscle now continue on studies CK Difficulty] question, to of in tox don't XX the we date the course. any any of [Technical we'll been rest on believe to the through We've while preclinical And have have chronic slide weeks XX other

Alexander Thompson

Okay. Thanks.

Operator

question Song moment our from for our comes the with question, next please. Jefferies. line One of Roger Thank next And you.

Your line is now open.

Roger Song

HS Great. anyone, for Thanks just for taking the the just I one. question the and and all I about data. a the hopefully, quick lot one CPK understand that's in you. Maybe CPK transient this the -- of questions the know very details And the have symptoms for of and it's the kind -- good, terms don't much too associated. appreciate results, elevation I sales not of and you

how usually CPK long have Just and And any on curious while develop may takes to and have they the kind the you therapy we take off if of be should you. this symptoms episodic Thank how elevation? some they for patients longer event? concerned elevation term

Douglas Manion

Yes.

nothing CPK dose safety date program. to so completed, date, XX having weeks. in that week in profile been But studies beyond tox able And only XX there's the seeing data to with We to we we'll chronic humans through have smoldering that in our there's now be that you we're chronic the XX It of CPK that to different there at would something think isn't it. be seeing on, was weeks, you're that through going here. be that would with if then there's at issues all but any might elevations suggest profile going long-term the

let's do that? relatively low. to add longer-term the Gail, follow-up. But course, the likelihood think I do the you is on So anything studies and want of

Gail Cawkwell

meaningful, I'd course. stays blood studies our thing can And measuring of up in And changes know of course, not if is only and measuring blood add is harm. cause goes we you seen haven't like your The that pressure. blood that, CK up pressure pressure any that are

it's It's your in do can CK going things And evidence cells. and that any muscle that underlying when those your something associated get in may sits that's not of something thing. a muscles, of that. harm with your no But muscle and we normal cells unless or you go you day on going CK, have biologic something impact turnover increased And to on body, else up. day there's your with

I as would transient even such a life something of to over So in in or the see course these are normal elevations case. in period our in expect CK of daily any you long time me

Roger Song

All comforting. Great. Yes, that's right.

have consistent those ever your In you terms you Anything you cytokine study. baseline a seen the can comment cytokine related Xb just the make disease Phase cytokine, know of yet? or your can prior kind Or us RA let data with maybe the for to of background?

Douglas Manion

Yes.

is a study. this blinded so And

top to we're cytokines not Phase looking look want But add in have line look looked terms in we we anything and So the Xb be actually at what until anyway, to the you study. at Joe, yet, about results. wouldn't of RA we going

Joseph Monahan

Yes.

cytokine So MKX the and of Phase levels. at on analysis dependence cytokines will be Xb the the IIa ATI-XXX. on vivo study, the demonstrated won't doing ex and looking these sensitivity the ex we in of already we be that endogenous we've vivo study,

Roger Song

you. Thank Excellent.

Joseph Monahan

Thank you.

Operator

of Dipesh our One Patel you. for question our please. next the Thank question, And line comes from with next moment H.C. Wainwright.

Your is line open. now

Dipesh Patel

Thank you, guys.

in Several you consider shaping Selvaraju, dermatitis? you be what the landscape Wainwright. do do to up for in see for standing competitive H.C. questions. How the ATI-XXXX? atopic Raghuram differentiators Just And key

Douglas Manion

getting question. attractive. great fact, The a in It's is more Thanks. landscape,

the been the on been of all applied the basically skin. launch pleasantly And we've is topical way, successful think JAK with I that's by the JAK. that just oral the surprised topical insight JAK

and So getting a the of likelihood it, is if not JAK is similar, do class so surprisingly differentiation a to efficacy soft level but significant area have you to exposure, which labeling. to with systemic systemic with think fairly high the decreased see better, labeling the I of Opsilura, the give black of not topical opted the them exposure number us one class FDA box, program that we're thus our seeking minimal with with why

seen from with you U.S. that until in we're be what our to Phase have the to we are look profile X be think, the finalized label going asset de study, minimis FDA, based minimal I that there will trying is we Xa But tracking to label well achieve. at just have patients, exposure data. what's and in the know discussions if Phase don't We in the on

Dipesh Patel

enrollment arthritis. the psoriatic be trial? What gears arthritis possible psoriatic switching might to just zumsemeinib Great. to And then in reaccelerate

Douglas Manion

be few we've get as doing in quite able seen And just the out, Polish the to been an We've part uptick with enrollment a just through these the government. it of difficult types to last months point of in is studies. hurdles to regulatory world

achieve want think track So it? to what Gail, set of you we to to are on enrollment But out terms for in we anything do. I add

Gail Cawkwell

very study this this I'd in like actions later. a as was of that, But closely many world switching sense. and the study, There with tracking it then more earlier, many, all studies particular improve. In to point, terms companies say of and to having makes challenge in the bit Poland. only our a said as is enrollment this studies, we screening part started the the them at track Ukraine of take seeing we going continue over We're we I with in enrollment expected. We're well.

So I think we're on track at present.

Douglas Manion

level lastly, investment high a this. And of have for we enthusiasm

part of enthusiasm, of are we're world in lack it some dealing So but there for isn't that with. that a headwinds the

Dipesh Patel

Great. much Thank you there. so color for the

Operator

Thank you. next One our for question. moment

Our next Harrison with BTIG. of line the question comes Julian from

open. is now Your line

Julian Harrison

morning. taking Good my for you Thank Hi. questions.

you to the endpoint, the curious XX if comment wasn't affect of score changes if for rate were, and primary specific the on that what XX, I'm criteria it and expect And the population. baseline would placebo topical curious then could high could you you the characteristics study about protocol? the how overall while data, then this just HS on XXX the on First, much JAK ATI-XXXX, talk more behind inclusion to

Douglas Manion

Yes.

of a endpoint. we're say Suffice that lot had good every not So the placebo into results on a HS. going basically details for regarding it more day very to

the to better published. successful want did that in been you X have active already placebo than fact, did more studies some comment do of in Atopic about Phase study In that? dermatitis, this

Gail Cawkwell

Sure.

dermatitis the atopic So study. on

on available And the repower literature to data start us study. clinical decisions. by mild helped not come I'd carefully look First, Opsalura data was kind did of that was in to trial patients. through where the rates, having feeling saying need we response the there Certainly, those and we

we the is do kept the with as but upper in mild severes, range the the What was we and is IGA which moderate did included it study. we X, Class

greater to equal or from X. to equal X We inclusion, to X also greater than for than from greater than and body also to dropped we this to dropped equal surface equal area X, or easy than greater

somewhat board, the going a including said, move population to simply we across And as is milder well. we screening as great there. So

Julian Harrison

Thank you. Great.

Douglas Manion

Thanks, Julian.

Operator

Thank you. question. One moment for next our

of Tim question next Lugo with William the line comes from Blair. Our

line now is open. Your

Lachlan Hanbury-Brown

is Are This the you quick in could enrollment milder new fall Hey. question. Thanks Lachlan into that Tim. follow-up the sort of dermatitis. on of on that taking for cohort. the for atopic the for trial A limiting patients proportion

mentioned If you could you a then be elevations, seem just associated CK Gail, talk about the that. with on of to exercise. lot And them

RA the like in PSA wondering visit. exercising before there or I'm things So and are a patients restrictions studies sort any on of limitations

Douglas Manion

of both Gail will those. take

Gail Cawkwell

Sure.

question. terms the atopic study, So in excuse of dermatitis what -- was me, in the the terms of

to me. got You tell

me? remind Somebody

Lachlan Hanbury-Brown

Are of you limiting the number trials?

Gail Cawkwell

at Yes, study sorry. of to enrolled all. And at in adequate see that want to still this the at. enroll, make plenty we're get mild We're or well we that, stratification but no, would sure mild at moderate severe. My hope mild, any enrollment for the have of was point. terms we room not of we where study We not certainly Yes, point enrolling. doing kind patients. number patients be of

study, at look a it you reality CK In terms if is The question. of the that the is population. younger much HS

most people from study anywhere moderate Our arthritis. skeletal are with really mean go to including as out RA with is type have entering age. severe mean significant problem Xa mid-XXs disease people for RA just of It's mid-XXs intensive and do regime. our the with as is Also, where quite to the unusual it disease deciding same a muscular exercise mid-XXs, a a in age studies, to to

of are a elevations always possible resolved we you the want world the CK treatment study said, indicative saw in that or real intermittent to study. the like anything on in concern That to HS restrict as reason not as increases a with studies. in things these really And keep

Douglas Manion

Operator, any more questions?

Lachlan Hanbury-Brown

That's it from me. Thanks.

Operator

for back remarks. I Manion Mr. to will turn the call over closing

Douglas Manion

as everyone to thank the for company There's All growth just of and make questions. great to again continues further interest time, future. right. a no want Have continued support day. I their our for strides

Operator

conference you today's for call. concludes This Thank participation. your

You wonderful disconnect. may day. now have Everyone a

Aclaris Therapeutics (ACRS) 8 May 232023 Q1 Earnings call transcript