TRVI - Earnings call transcript Q1 2021 | Trevi Therapeutics, Inc.

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Operator

Good afternoon, and welcome to the Trevi Therapeutics First Quarter 2021 Earnings Conference Call. At this time, all participants will be in listen-only mode. [Operator Instructions] After today’s presentation, there will be an opportunity to ask questions. [Operator Instructions] Please note, this event maybe recorded. Various remarks that management makes during this call about the company's future expectations, plans and prospects constitute forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. section materially result indicated including Form of in Risk differ statements these those XX-Q, may most afternoon. the a company's filed as various Factors SEC which results the from report with by those forward-looking discussed recent company Actual quarterly the the on this of important factors,

views subsequent relied views today and of addition, forward-looking upon representing In as as any any statements only represent as the company’s not date. the be of company's should

company specifically the update so Officer. turn Please I to forward-looking obligation Bill While are Participating elect may these like Therapeutics Good, the now the conference ahead. would do over Trevi change. Jennifer statements to and in Forbes, point President on Chief future, at from CEO; go Jennifer. to today's even to disclaims Development some if views the call company any and

Jennifer Good

first call Thank to everyone, and afternoon, welcome our earnings quarter you. XXXX update. business Good and

on Dr. to answer today call available my remarks. prepared me is after be Trevi’s Bill Chief Officer, will questions this Joining Development who Forbes,

was quarter. six Our and call clinical our progress will the update on only giving earnings weeks our development I ago, reporting for earnings focus last on first so an

as the approved Our of is and in with currently in as nodularis and debilitating are is of skin, to this the pruritus and a the nodules incessant patients, the program disease spread and papules There and clinical chronic prevalence serious XXX,XXX world. continue a scratching, PN XXX,XXX and for disease, itching. estimate We U.S. no characterized nodules is in of most because well advanced the or XXX,XXX patients indication. development repeated the the is nodularis on rest and approximately worsen. in severe prurigo can PN, which therapies by Prurigo papules global

us for development, in with the we believe PN, are we late positions phase only potentially unmet there competitive the need. advantage which candidate for oral development in biologics serious are an also important Although, non-biologic

condition, itch based We in are enrollment. on Numerical is is call currently and endpoint by conducting PRISM our weeks a planned XX recruiting as this the measured trial analysis We responder primary The or blinded than study more reduction currently Europe. trial Rating the the And in have XXX Worst approximately have fixed Phase intensity after trial. trial Itch The randomized activated. both the XXX XX% the sites dosing. U.S. of in a which we XX of of into subjects in today, we than Xb/X greater the PRISM Scale

We are than very this and rollover encouraged of provide percentage in also disease long-term data will an efficacy We cycle, trial. feedback by these greater potential healing endpoint has and but for a into the important extension XX% time. to continue modifications itch from and portion life that complete around high week have scratch subjects that therapy only safety This of disrupt open-label not of the the eligible data, resulting effective to of itch, leading subjects. XX symptomatic the skin site the treating by believe reducing quality the healing skin and over that to

new that good implement have sites to subjects. and group recruit find sites support and to identify of and a continue Regarding we continue strategies to enrollment, the

desire broadened may third again. for travel and a We enrollment of months during August to to quarter knowing and we completing year, guidance the year, continue the July people second for to COVID the the our of especially in restrictions slow half of have bit, this push but light that summer of easing enrollment in the

the enrollment hope there runway will on call, be a enrollment our is when for and by left We short earnings I will announce complete next study.

development team the In move clinical addition the in for indication. is to next steps forward to preparing trial, this executing on

recently The of approved designation the We for conditions expeditiously. to so Fast designation from product that that treat serious development the can proposed this an the and drugs Track Track to life-threatening FDA expedite we is market Fast review received intended and are announce indication. excited to facilitate reach

Turning IPF now the scarring to a our which fibrosis program chronic and progressive second cough tissues. in pulmonary severe there idiopathic clinical is or in for IPF. of is condition lung

symptoms that excess approved in associated improve the are patients high IPF to looking the which with it approximately One there which IPF, progression their of XX% disease, and to only also not debilitating estimated, Due there life. and is of leading this that no coughing, for no affects therapies in is these suffer of prescribers therapies. we amount mortality equal the patients estimate patients In approved IPF. an X but are to Worldwide, currently Europe. XXX,XXX patients the there disease the with are XX% from of chronic slow condition. this are of of U.S., and approximately There million serious are quality five-year for

lung We with cough endpoint arm. are change primary week assessment in restrictions they from baseline. and frequency and conducted to group contract COVID-XX This frequency a treatment The UK X that PN is if being in conducting by this digital due cough has significantly considered monitor double-blind placebo between study than patient The given XX-day each high risk, the period a is our the is trial COVID-XX impacted washout crossover three treatment measured study. daytime by been impairment, between more daytime their arms. Phase trial the this percent cough a currently mean is

estimate these are were the in their condition, Due shelter-in-place for December. to see to we the early issued patients IPF prioritized the patients fully were COVID that vaccinations. patients in And We which UK, are vaccinated. of of these for restrictions happy most lifting now

centers trial. clinical We of this have been for closely to determine for our timelines with research working reopening

their quarter. reopen treating have to to approval sites of note the COVID-XX see We to trial, some received research, this Today, to several investigators are returning resume prioritized and past begin to and over Many those encouraging started and expect of patients have been reopen clinical seeing clinics year. we staff enrollment research. already staff for for have our screening that we the sites had

will our enrolling. the work remaining to with study and in the of qualified fully sites up to UK We continue all closely get

study a to As this a XX is enroll approximately XX reminder, designed getting completers. subjects of with goal

we So get enrollment, some can we if momentum optimistic we are in study get finished. the can

update a on Just quick Germany.

to was recall, add on may pursuing and that board We As sites effort. you make study ethics good approvals did regulatory Germany. in potential Trevi progress

sites. current on status of we the completion will pandemic add in Germany clinical Kingdom, both are With However, on the the restrictions our we enrollment XXXX. have focusing the United review easing our now financial summary I in new opening of due for the and these estimated Instead trials, that pursue of in of light of additional the results quarter not in efforts decided timeline sites UK. to cost first the to to

As be the market press a issued of the and in XXXX this release ahead for SEC our quarter can closed. was call reminder, the full the financial today our of found results with filed after which first XX-Q,

ongoing XXXX decreases ago. based were loss that liver quarter million the fees. we For in a the of loss net and clinical chronic the The expenses The to in $X.X $X.X first million related conducted $X quarter expense. XXXX, decrease disease same compared was completion same $X.X decrease with compared were activity timing trial These expenses trial, to decreased purchases during to PRISM as in compensation XXXX. is million increase for primarily decrease during of personnel of an largely R&D which year in to XXXX of first well primarily consulting and reported we in Xb the due period Phase patients in on period $X.X of a the our our of net supplies, professional an million $X.X million were first XXXX. was expenses G&A the clinical enrollment of of a as to offset by in the partially of due million stock-based trial quarter a compared quarter increase and same of XXXX.

a runway to remained overhead have our with consistent We relatively at respect costs.

$XX.X XX, XXXX. of XX, million December March cash million and to As our equivalents totaled compared at XXXX, $XX cash

into is to Our second current expected cash fund quarter the XXXX. be of operations to sufficient position

we understand us the cough can anticipated the remarks. from trial results Beyond we line is we another out PRISM full That trial. cough also of timelines see prepared it carry the although to enrollment for quarter before for top need and enrollment all have coming believe the of to our the COVID-XX enrollment can two I restrictions, the or of

back turn operator Now Q&A. to for the I'll the call over

Operator

Thank you.

Please Annabel go [Operator begin will Today’s Instructions] session. the with now first Samimy We ahead. Stifel. question comes from question-and-answer

Annabel Samimy

question shows picture in quick ask Hi. opioid the I but update. same oral approach. the about opioid not think to activity the predict bigger quite It's actually mechanism, was receptor a the wanted validating and population. I Thanks kappa two for

really to still So something bit at of very have the we clearly think an two that And itch of dual where a AD is population. consistent, these of kappa behavior with is population, to in I behaviors the And very least fact predict approach. different very populations little guess I different what the the to it's is understand But difficult yours difficult are peg. in even itch that evidence mechanism. realized I there's the now

bit to, of I can these just maybe studies itch draw manage endemic what a guess, a what you that. variable could can some do speak and So what is very little in problem? is population, it you you the be can to PN about where that even So broadly from

Jennifer Good

Bill. Yes. Go ahead,

Bill Forbes

Thanks Jennifer. Yes. Annabel question. the Thanks, for

of kind given step we've me a through of Let lot obviously because thought. this

talking kappa an you may actually peptide. the as and think is that I opioid about

an know, oral very behaved distribution you our molecule and well from with perspective. is formulation, excretion our metabolism As nalbuphine absorption

it it dosing scales half-life the formulation parenteral on linear within It our nine to two been and hours. for fashion, to range oral formulation. from market from formulation has this the prolongs a increases in the Our decades

has a So we profile. It's well-characterized that of nalbuphine use know decades a parenteral. got as safety

clinical XXX over in have controlled the trials oral using formulation. We patients

perspective, in think is behaved. and very this look we I respects, well many small So molecule a at safety as from efficacy our

this is at take drug data response. able we've in things effective very populations, patients statistically and this study at to a know the and show effectiveness we're done different from our that job manner. for dose looks We and using mean, the we one this a with based is a product is I uremic very pruritus using that that I As And it's increases look formulation safe XXX of think its significant that upon that. dose key good

when in think our start we case, to kappa compare dual we're mechanism. I different that agonists, So and

peripherally, What pruritus. talking to show be receptors brain. implicated a the mechanism – believe to exist part continues that that believe the neurons, there will same working has the is itch have So into we only we're successful from the believe into way the in the about here, peripheral skin much all because that exact treating of not but on spinal opioid results the you're that not the that right, we do centrally we that but a that is potentially better drug cord been up our effect mechanism pathway

So opportunities for our about to areas the effective, penetrate good and those all to ability us here. be we feel

So better and if relates I the pause. have mechanism I'll than like difficult showing these competition are much to that, different as any which you populations, benefit questions. is significant with treat, of And why to it in we they some maybe think our

Annabel Samimy

about. have the PN population they actual a Just that it anything it in way the itch the could could could, PN it in variable – we population, temper, such it one more – should be placebo do on concerned have could sometimes response, a of be that population

Bill Forbes

on they six. scale the WI-NRS are zero greater it's this where recruiting that for score way And we've study, at have less any one recruited patient they I goes can't that from population so difficulties homogenous baseline particular these to and than I of seven patients that things the a we're point think the XX, in scale. an the is XX or we've that that mean, done, looking scores

scoring be consistently So they're at baseline. to very very – actually they seem

they fairly isn't once PN drug studies placebo that but then placebo is consistent the into a be Of around have It's there what think for a looking The will response. anticipate not most we're part, say effect, get the population. at that can I the the and a response in XX%. stable course, we to study, treatment here

Jennifer Good

a itch, the tell think PN they Bill think things just thought is I question worry would that I lot Yeah, I about? pruritus, I about of asking there there's the know. we Annabel, uremic triggers underlying add you mean, time what obviously sometimes I of to atopic over I you're is, don't about can derm,

always, going see And it'll of Bill helpful to that. see that homogenous And FDA any peripherally, triggered can, differences, we do all be we centrally so are didn't since underlying think there, and they mentioned of to was, a data is but drug variabilities. depending we our is I X they obviously interesting. place. even will trigger I on on they diseases works, as though our interested sort my and that's force the as what In both the there know Phase think survive, different that have mind, as population but PN be the first in PN

Annabel Samimy

Thanks great. for Okay, the color.

Operator

Gary Capital today from BMO Nachman with Please And question our next comes ahead. Markets. go

Gary Nachman

Hi, good afternoon.

few this to quarter, went So enrolled from you months. last a XX% from about two-thirds to over enrolled quarter

wall hit accelerating a little data, because in slowdown, of I'm last months. of seeing but there, pushed more curious summer progress the timeline in a out you what some be definitely enrollment, terms for mentioned of a the little the of bit been pace you've could So but you few

Jennifer Good

to you on Bill want it? comment

Bill Forbes

Yeah.

Jennifer Good

Yeah, go ahead.

Bill Forbes

out, our from guidance mean, QX mentioned as, to earlier, you and I Jennifer I half. we as obviously mean, moved second point

by seeing the And things banding rubber that bit enrollment little we're is one kind of a of so on of month-by-month.

So a vacation it pushing gives finding months the to positive thing confidence is, staff Jennifer up, we is study also our we talk to us staff mentioned on when as as to mean, this we're daily basis as and I the people and side the regular enrollment but we that they're engaged. on think the makes I the staff summer the investigators, – that study that us, into very mean, hard that very anticipate centers pace. about we we study moving on and there give I are try feel guidance But are with wanted good obviously here. as But as see talking we side continue at trying to can, to They coming to we'll guidance them ability completely keep and basis, be I best update responses good take the along go to mean, things a that difficulties I from is may as we're get we some patient to get the they the them. so. we

Jennifer Good

only our last would was update you six weeks I and ago. Gary, as know, Yeah, add

things round. where sometimes So just we and of it's you these cut do sort

So yes, I and around go come XX, would of but up to generally down, say seems consistently it we've it XX, around been this that sometimes averaging does it's sometimes it's XX, number. kind but

Bill Forbes

answer from I But seem of from at of – with year months. to keep of the look the couple a little more of of pace last to question, months enrollment last months of or previous couple kind your think directly, the best The previous so. some I kind

increase couple we continue of as to enrollment feel we know way difficult to the a looking obviously goes last through summer months. we a forward, time in that the in the So months, of good have about activity but this

Gary Nachman

Yeah.

could add very there? at sites but think you current you to lot spur that like on a you sites presenting chance maybe need bigger awareness just where as it you at patients any sounds point, get the one what do Bill, I don't into good or I these to you of or that, do then mentioned, last especially a know, of accelerate, you're the so initiatives sort do community, Jennifer in maybe feel XX And need you So you like sites that to summer. the out have PN these we number enthusiasm of feel sites, that, or with

Jennifer Good

Go Bill. ahead,

Bill Forbes

number got talk mean, constantly about we've I at look this the me that sites. of couple no, think, still of Yeah, sites here. a board we I are and on let coming

on and had our So and countries, up activity, a that France we're of the heavy particularly Germany other lot not Poland, the not it's picking this activity adding a Austria. they've lifting and in U.S., we've study but sites, see great of lot we in done

take So this we through leg from horses now that feel us can of have think last like site right we I a perspective, the enrollment.

to as do far you'd We that what constantly doesn't we we refining the works of that do, lot As and do do. us a We're we learn and work. expect what advertising. what initiatives

site with that extremely taking working sites still a sites we're to do hold we And and have we've started that March. it, We advertising they're at with and that try in done, as are level, initiatives February have successful and to them. as now. find way roll recruit to we those out the to far But the better

the – that this what we're hunting. and up, of in think ask. drive But day get staff to every to of and we're coordinators we going home. what investigators is respects, this hopefully I And our trust we So me, all are it's try study fruition and wake many

So can. we're driving as we hard as

Gary Nachman

you focusing UK there but UK? Germany doesn't and on It's IPF. how many opening resumed some enough, if some could bit that. sense confident reconsider have done here, little have to if reopen backstop there, going you up that on screening and you at where how one just wanted in seems make like getting many pretty just if a It the to the Okay. sites and point? And progress still then confirm the just last you're UK, sort but see nice that's you get be other any Thanks. you're Germany it quick of to isn't to do also is

Bill Forbes

how investigators enroll. and a to I have that Germany. at the that strategic complete in opening much German time long would for kind timelines take Yes. we look management up was might of How centers obviously think to process And the this as call,

in look And away at I what a seem rest the Germany now right and from them coming this in we'll about third in the screening time of sites of would is, online. are be adding looking UK. we're say sites the actually at So to engaged pivot to with point

I investigators the screening month good all from and fact future, that they think hopefully randomizations will centers the think distant very know centers ready for they're too to the And calls you But June is the we work, going some I of the to study engaging, away a everybody with back goes, set screening here exactly have gets end go And that's the pivot but result we good we're in to how who's are that the in. that so are staff how into get us the COVID, this. in as sometimes nightmare. not to these through. be understand to through up not to come UK, in feel got treatment pulled COVID now pulmonary

July And we're timeframe. doing looking they day and do good here getting their forward come as this of to back out job research, the some June, in activity so,

Gary Nachman

Thanks color. for great. the Okay, additional

Jennifer Good

Thanks Gary.

Operator

And go comes from & our Needham Please ahead. next Belanger question Company. Serge with

Serge Belanger

Hi, good afternoon.

from useful the readout? that we we endpoint, itching be Thanks. the saw about anything to as different effect Just of missed for is seeing readout? a a trends of placebo a into anything rolling kind it's on know discontinuations? patients you updates But recent questions I similar Cara over I trial could but extension glean any similar your into of we can couple it prepared are PRISM look and study, this study the me. so the comments. occasion, Maybe that And then

Jennifer Good

your Serge, XX% to to greater not you private had happy color. of saying don't the year success did you way a But but my then than make alternatives. and in end, should over, clean – make you still. very I'm other a everything. we comments I'm reread sort We've script a going with way add are get to that of know go setting, we couple out the people patients their the as these of all on have treatment, stay only through roll good and study

I down. it's we But placebo the bit think to on I can to line comment there. actually seen more Their range studied As relation that say have may too studies, thought, these the with in where you studies. that been And in that. that and Bill in the would I because would same want discontinuations far with on to them Serge say SSRE. in as a we've little we've I Cara color effects typically manage continued Bill, add

they think I XX%. what, were XX%,

helpful. I I kappa own that's bias, think believe opioid I on mean, mechanism, in my So I agonist feeling the work. my think Cara

just formulation sort in think oral that's his of have its I I Cara And a do convincing. really outside that to is alluded I as think challenge, has comments, Bill think in of to the injectable show way struggled they've down. they formulation that

it So chime There and those well. Bill, of indication. is I thought of on itch going your so you is tricky with with lot But – there everything are lot was validating, thinking derm should stuff a multifactorial think I atopic and in a a my as else. thoughts. inflammation

Bill Forbes

had active dose the because what we size we actually I their much the what versus they from Yes. here, my I placebo. review had picking are But at before, take that, an To they three That's guess a going in a not study. was comments anything, had pretty knew so would you I covered well-behaved, if and did a on. look I into dose, re-estimation. think, our we up formulation molecule color the sample she study, think doses obviously probably add ended interim they

have that conditional And final end we a picking – study. power be to so make up We about promised do to with dose in and all what the amongst we had different for didn't the had we to just sure end then doses. worry should is

So group. we patients, XXX per XXX with up total power of treatment ended a

that chose. dose between doses, I ended and the per they XXX with two think Cara up about patients placebo group the active

I you we out indication as pointed different results, at look before Serge. of kind those So, as mean,

about up They on there be seven that greater or always enrolling end is have that. do a to so scale. patients And have the edge – cautious we gauge

our about in up feel we're feel number and in. good We seven we've we powered on got many position same WI-NRS. But respects, or are the feel So I like the think like we greater dose. we're enrolling we our

Serge Belanger

Great. Thank you.

Operator

I’m not questions. any showing further

turn back over Jennifer session. So this closing concludes conference to to remarks. our like question-and-answer for I’d the Good

Jennifer Good

thank Thank hope all subjects you. everybody everybody participating summer. study continue has our other participate nice who clinical our Thank like call. the Trevi thank also you. to like today's I'd in investigators to a for I and to We'd in trials. team,

Operator

you, This included. conference Thank presentation. you for ma'am. is all now thank We today's attending

You have disconnect and day. your may now a lines, wonderful

Trevi Therapeutics (TRVI) 14 May 212021 Q1 Earnings call transcript