PRAX - Earnings call transcript Q3 2021 | Praxis Precision Medicines, Inc.

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

Operator

Good day, and welcome to Praxis' Third Quarter 2021 Update Call.

As a reminder, this call maybe recorded. I would now like to turn the call over to Alex Kane, Vice President of Investor Relations and Corporate Communications.

Alex Kane

Thank you. Good morning everyone and thank you for joining us today to discuss Praxis' third quarter 2021 corporate update. Kelly. call our President Ravina; Chief Chief Officer, today's Officer, Chief and on Financial Souza; Marcio Medical Tim me is and our Executive our With Officer, Bernard focus Please on along note a on results. XXXX update third brief prepared that remarks with recent and pipeline today's business progress quarter financial our will

our are the Events & will to slides supplement on We Web throughout today’s section posted of Investor be referring prepared Relations site. remarks, which Presentation

already them done access So now have not if so. please you

want Before statements proceed, to assumptions, subject predictions forward-looking development could to the implied reflect regulatory from Private that be of We business materially of you beliefs current we operations, that uncertainties. would I and such remind pursuant call not Act Safe statements efforts, will Harbor XXXX. available Litigation emphasize forward-looking events. Actual these other and provisions our this future or our guarantees differ those and statements are that statements like or with we facts call, among statements Any are neither be during during historical Securities the to are statements Reform to forward-looking uncertainties that currently by intended regarding, today's due and risks various risks to making made strategy, and business. stated forward-looking to things, of expectations, nor and current results associated certain our are of data

turn well Marcio? the call associated statement as Marcio. as on you consult forward-looking to risk slides additional disclaimer I'll SEC to For filings. over encourage detail of X the the with now our our I factors the business, on Slide detailed supplement

Marcio Souza

the for of as share its morning, recent It's progress on to what's Alex, NASDAQ everyone. month, public call to here, all be and Praxis you. a joining you, one-year today. Thank come our anniversary and Stock we're Last glad Exchange. celebrated good the and company to with great Thanks

we've at take we come. ago, a natural how were where back year it's to Looking far inventory for

been of and bringing a make company, over and progress physician do to in it again. a drugs to able needs towards we've have significant be As over able practices number CNS people to to of the goal

a you'll We more coming and saying at one Praxis, and have here months, in hear the More. for that more Dare

drug and year, While we we for working past More foundation like are the Praxis are proud and what come building advancing portfolio, every our is to developments every are pillars, three underlie four to advance work progress. approach one for they foundation and we do. which of the key we seems our in on our aspect in how the each approach we've From our in efficiently. patients problems multiple so of This day. across far to to based is ability we cells of everyday hard so the Dare

targets validate we through genetics. First,

encephalopathy. While gene progress, lead this targets and cause devastating principle the which PRAX-XXX an provides candidate ideal can a program, epileptic in mutations example. applies PRAX-XXX to of our ASO our SCNXA an rare preclinical all

which this the the our indicating targets. or reveals drug is the development upon translational later whether selection supporting initial genetic draws findings pillar its program. leveraged such from will as and electroencephalogram, he in second EEG those help The EEG, and Bernard reaching tools example, when PRAX-XXX depth highlight for by, inform more findings

Phase symptoms. signal provides and a with and learning Xb with of women to or strength move applies and executed pillar proof rigorous positive depression, our trial paths in results perimenopausal efficiently for them third PMD, leveraged forward to to mood PRAX-XXX menopausal The this in supporting recent The concept. development the study decision

and both eventually stage which essential MDD these significant pillar encompasses the and everything could our Praxis, early do developments stage we in in evident Patient-guided disorders. this research from Ultimately, Finally, strategies. tremor, commercialization. at with developments particularly PRAX-XXX address fourth PRAX-XXX patient-guided living development needs implementing lead unmet people into is in about programs late for

fast-acting or combined of with the months would from takes that a the PRAX-XXX, relative existing not effects certainly meaningful show weeks for antidepressant to days, improved their to potential depression. people be suffering For therapies tolerability

can pipeline as For each foundation PRAX-XXX, in expansion our when quickly patient’s soon promise. out that be highlight developed be new of trials and you or that’s approach multiple progressing considerably our of a the in at a has significant ideally clinical the potential in treatment indications, led Slide which daytime, within holds point The given see activity impacts portfolio. to most I'll growing, to the currently existing to X. option, three on tremor diverse programs is possibility

in In trial year, by the which the would next our portfolio PRAX-XXX represented advancing preclinical first-in and well addition, portfolio. the fourth we anticipate pipeline of first is to program The of which slides, end the have This maturation is in registration our in we shows a initiate to half how ET of recently that by patient a PRAX-XXX add the placebo-controlled to trial trials and XXXX. MDD Acapella study PRAX-XXX EssentialX dose-ranging following ongoing initiated. monotherapy area and six active of the includes expect study

Bernard, studies Friday, has PRAX-XXX, the programs as upcoming clinical X December to York a XX. in we with studies will our on in for rare well City program, focus call to a adult will momentarily. this illustrates be Slide quarter, stage PTSD, for the New that X which This PRAX-XXX led expect patient we'll I share the discuss approach coming of readouts and to, Phase Disorder initiate foundation cephalgias. period X want catalyst-rich what Day Movement to hosting trials in in Bernard for clinical year. as tremor that first-in clearly to each third our Phase in Prior passing essential

imagine, with trials focus programs our As in ongoing tremor, the on will can and there. essential you multiple be efforts

this a Parkinson’s non-dopaminergic for treatment is franchise. the motor disorder’s PRAX-XXX going symptoms just movement in for beginning for why as are and also to opportunities We discuss highlight the the disease,

you ET, assessments. look clinical our results expect view comprehensive into a of For today a can our market and

and faced pharmacological on the burden XXX. with leading living you regulatory people essential for to updates tremor You about treatment XX paths ongoing the We're by and advance first PRAX-XXX for essential provide hear in excited the both years. developments and in be also with efforts more tremor over

Following of December, Day Day in we'll Disease the in Psychiatry our next first hosting Movement Disorder Day a Rare be half and year.

the we year, our on in quite of half In our later PRAX-XXX from there's trials our remainder ongoing Phase results all forward to to the next MDD much starting patients to top to first line and up study is anticipate in stakeholders. deliver this nicely year. and depression XXXX While shaping of look expect X the a year, promise in

in initiate line Parkinson's the the States. Furthermore, in to for the XXXX top half half study, first share each PRAX-XXX the indication we one dosing ASSR also X for 'XX, biomarker of of of PRAX-XXX those for Phase for which plan is first Phase We the in United results a in DEEs, programs. disease a study marking and trial second in PRAX-XXX X currently

this line ET. end in before we Also, of line us from expect can PRAX-XXX of of the plan Praxis' be trial Phase the to from the first study XXXX. program, top be stage. Finally, X reach in for the for In Phase top and our half portfolio ASO first the in and start first year, in EssentialX a will will which the trial would to PRAX-XXX PTSD we results in next second provide allow to readouts PRAX-XXX half clinical X/X initiate ET, which we to XXXX, in-patient ongoing study expect PRAX-XXX the ET

As Ravina which through our you volunteer X studies, ongoing I’ll provide to Bernard? look pace walk into over you healthy completed. fully keep our PRAX-XXX see, and progress now to upcoming Dr. to portfolio. the well Phase can just pass up to call we we as data, intend as the a throughout

Bernard Ravina

To comments, made designs echo slides line looking great the have we've quarter. briefly it's Most next clinical to both currently studies studies. Marcio's be Acapella you. forward Marcio. are X, and the of more trial for on progress I in before, Aria design so details, instead I'm results and we've this and PRAX-XXX here providing trial included X the the with confident Both our half of ongoing trials perspective to On and important an for you slides the studies. call delivering year. out wanted to top these of all in enrolling, seen the of reviewing we're first Thanks, aspect

the out but the endpoint after weeks, see, weeks. continues for critical This period these two reasons. can is blinded two you As treatment trials for for is primary four

that of allow PRAX-XXX. relapse, longer design The resolution in believe to be of we depression months. the and resolve we whether both need that symptoms, rapidly fast several patients ensure is support depressive to onset work episode with through prevent and would several an episode treated weeks that demonstration and and to will First, with believe treatment or completed consultation was FDA, for term XXX

design this is thereby is be the the treatment the tends in of towards maximal the the effect endpoint. treatment noise. the signal period, separate help primary of to case weeks two placebo end to expected Second, Aria and end after period and dampen Placebo studies, effect from of and the Acapella

quarter focus for data Phase Moving come indication we've for a of confident PTSD And clinical well GABA on of have of 'XX. line documented benefits alone. PRAX-XXX estimated A PTSD PTSD by we're an growing historical with profile steroids for steroids of adults we in approach could the clinical proof-of-concept aware Consistent impacts we in date. the U.S. addressed a shown strong PRAX-XXX the Also, And severity. be we're XX to stress-induced and mechanism to with of challenges top Deficits on has and here. with PTSD. Slide treatment million in study rationale developing this believe and PRAX-XXX and our psychiatry, fourth our of the need are natural the a with second is response in XX. action role starting there there's There's its in neuroactive in of treatments like X patients anticipate neuroactive that 'XX, depression half symptom to in and marked the on in in while models XXX correlate stress. mediating based preclinical PTSD, to XXX. been in seen

be in sleep in Finally, clinically would the and as onset with the seen very in if effects XXX depression important PTSD. antidepressant rapid replicated improvement well anxiolytic as

I'd We that a this to XXX tremor is essential when function can is so Next, to without ET with study. The day. tolerated, can the discuss during they believe if the day. throughout taken well improve tremor people that of issues like our goal tolerability determine need medication PRAX-XXX trial

doses and note to to suggesting tremor of will [indiscernible] XX previous human In be to or assess pharmacodynamic large needs. Xa of this milligrams of milligrams as the XXX range treatment day this amplitude data over PRAX-XXX XX%. B X studies, reported and ET the correspond up of four trials. of range. milligrams is XXX XXX effects PRAX-XXX open studies. which In to in label volunteer movement crossover faster A 'XX. data tolerated for for We're in XXX safety study. with single that the data ET withdrawal initiated dose study milligrams SAEs half preliminary milligrams, the trial no efficacy, or trial titration healthy us mechanisms and exposures believe select on ranging to PRAX-XXX, of X tremor. that and flexibility dose-related population, in regimen of program of report fortunate the ET. This weeks. of EssentialX we've of And in or placebo, patients milligrams, the dose It's up of of pharmacodynamic has patients study XXX measures previously to and have going preclinical in milligrams first XX will about volunteers in arms trials from from address of dose this of important made assessing label Part In later tolerability released Phase safety and that tolerability subsequent We Part may across during the doses healthy a to randomized trial. therapeutic we encouraging toxicities. XXX broad limiting placebo-controlled suggests previously the forward. and severe to B three the disorders regimen open model blind, of XX, parallel our reported distinct We’ll Xb from titrated XX titration in double XX and Phase safety EssentialX study be in support in in our Part humans that EEG with Complete This faster to the Based on Our overall a confirmed for of allow patients, year, the a in randomized, ET good of assessed is regimen Phase designed a tremor assess and dose saw XX XX, dose will these we've for the ET a effects results well XX profile, was EEG effective to moderate progress XX-day reduction clinical XXX lead the in period which doses about we a efficacy and will two the we've XXX three-way profile, safety, preliminary this of a over ET. dosing range of

year, will study data second trials of to expected 'XX. the in from start support half before X next which Phase our of line top the We expect end the of design this

Moving highest and emergent XXX were milligrams, generally severe dose hours Cmax. with the we've portfolio, effect. or XXX completed was mechanism adverse action mild, PK, dose they of the for after transient dose SAD/MAD PRAX-XXX around studies XX XX the peak three concentrations Over Consistent tolerated. no Over our there was and the dosing, show the AEs. four was drug-related of Food X days to single SAEs XX% observed half appreciable with and events of data, our to treatment days to XXX well for a highest seen were were XXX multiple milligrams We days. rare were for five time life Effect PRAX-XXX. Phase no disease two dosing. generally food on The of of preclinical studied and proportional

Importantly, that data are the efficacy exposures models. we on in those excess epilepsy based in for preclinical achieved well of needed

on in exploratory trend highest of dose-related XX% biomarker a our steady saw at we XXX state reduction response. dose auditory the Additionally, over of

study channels. used confirm to ASSR response on are above And occur of effects volunteer epilepsy state concentrations EEG the paradigm, a data approach measure with with follow-up at EEG measured We for healthy exposures to ion on As this These EC in in started findings steady to four U.S. stimulus. our ASSR tended extend other the findings auditory an weeks dosing, models. the ASSR XXX. we programs, we have well and the where consistent will in over to preclinical our XX pharmacodynamic intended which changes clinical

us we to report and of this Neuralgia expect dose from data, this a the therapeutic safety on with Phase Based plan of a top of study 'XX. is X believe in line range. what data patients, to trial of in trial the We half SUNA ongoing the results and encouraging tolerability adult the in cohort in in a before a these first give The year, Phase SUNCT we end Trigeminal of cephalgias initiate cohort profile and patients. XXX, X confidence follow-up

start half a of 'XX. Phase or encephalopathies, of the DEEs, first epileptic developmental in to plan treatment PRAX-XXX for the also We X trial

tremendous As continued a progress excited over turn financials you've the an the Tim? to progress on of trials. our We're to these the update for for our we been heard, portfolio. months the Tim across now coming number I'll there's readout in call quarter. as report

Tim Kelly

key financial you third today. of and I'm with results. press glad updates file the will on SEC a quarter third would focus quarter Bernard, Thanks, to everybody. the our morning, financial to for review all morning's join refer I good the XX-Q and you and the comprehensive on release for this

of quarter XXXX, to today's trials investments, end quarter-over-quarter Praxis end cash through million of $XXX operations in approximately $XX the readouts data of of the As the a million. fund compares quarter, discussed expected which This of and into is quarter of third the decrease and to second call. had on of and the million as $XXX XXXX, second

as from of through for as was third quarter-over-quarter driven which position pipeline. the leveraging second approximately third by in and in trials. quarter, breadth expense. due we charges quickly ongoing the the advances. the million, the to the accruals expenses roughly of XX% growth during primarily assumptions comprise More the cash With primarily operator. approximately from expense R&D the in Dare non-cash growing quarter clinical These cash back for higher compensation cover the expenses quarter, portfolio quarter roughly with and expenses. efficiently related as that prior to with were line The to soon is R&D was our advance difference quarter-over-quarter increase quarter, The is in expense now be and Operating the expenses to call and and internal operating for R&D growth $XX.X that an an our one well way remainder Praxis has of Q&A expenses turn Alex initiated operating increase to portfolio to million effectively our strong investments on being I'll G&A expenses XX% with stock-based $X.X increase operating third developed, of

Alex Kane

in to Thanks, thank Tim, and everyone you today.

For the question that to ask limit you we one Q&A yourself session, would initially.

have questions. free open the feel to the follow-up please to operator, feel please questions, With return free you If to that, for line up queue.

Operator

Thank you. Instructions]. [Operator

Ritu with from Our first question Cowen. comes Baral

line Your open. is

Ritu Baral

Good Aria at about the ask I how looking and wanted the guys. in to some Thanks for you're morning, the question. Acapella other of taking study. endpoints

points? and early the considering treatment of do trial about make as ultra-fast guys GABA being design did be given those other think placebo mitigated. you paradigm sort two How has different going walk that Are you elevating chronic elevate in studies? to Does the of well. time sense Day these to X? through agents Day You decided anticipating X But us why one a you're

Marcio Souza

hear for nice question and the to you. you, Thank much from Thanks Ritu. so

here, trials. we've GABA these what for see remind and maybe agents development our go depression. expectation of So back consistent on From the about how we right, been pretty everyone let's the perspective, for

acting fast. them expect So we to fairly start

on I regard, to of discussed in effect makes bit for quite prepared remarks, benefited, may, see, just if for only our X would script to we But matter maximize longer. holistically expect sense trial, the of what pretty days will action importantly, expect today we commercial there. seen truly setting, on terms we of Bernard days. benefit the that's or XX we the in and as or us benefit So that before. it around will. them that weeks we've in patients as dose a little like longer part in also going But that Hopefully, for so, fast, -- four ever on the keep directly drug discussed like to get do allow a of we if And that even we going if his anywhere

rationale, have plans right on the maybe your any don't bit pointed we question. change to be data on clinical Those any We salvage have the and to the this based were don't the to be and So FDA well right depression. preclinical would way we trial. and were not plans, trying little discussed a We're have on more endpoints the now. with towards they treatment

to We’re patients help registrational to and trying needs. get to that be in

Ritu Baral

I'll in Thanks Got hop for taking the queue. the it. question. back

Marcio Souza

Thank you.

Operator

Thank you.

Yasmeen Piper from comes Rahimi question next Sandler. Our with

open. is line Your

Yasmeen Rahimi

secondary thank just of out, in going endpoints you as to call would be hosting Team, you your at questions. are Thank Day the maybe much a taking as my and be understand good sort to team. to Aria key you start Hi, study, pointed place well. XX for so the for

a of Aria maybe going might continued And duration for and the to be about to So investors week somnolence really between over the I be do look we we treatment over from what versus month. dosed are classes duration when to that's it month? important that patients two guess sort sedation cadence of because at and other know in of one data currently are compare I lot taking development. think a

just thinking helpful? commentary be we about that it, If would you very some be could how should provide

Marcio Souza

see to going that Bernard we and I’m XXX safety on Absolutely. question. discuss your the ask profile address to

Bernard Ravina

Yes. question, the for Thanks Yas.

overall. preference versus profile synaptic. before, As population at the very somnolence believe extrasynaptic that’s not we've were to receptors depression volunteers next like we seen day tolerated who due have have healthy a or GABAA We the in relative well And in anything dosed. seen we our really

it's little tolerated nighttime, So of desirable, Cmax. bit short it's There the around a a board. lived at been well very across which effect hypnotic is is but

upfront, with terms dosing we but the general, occurs respect recur can variable. interval, somnolence where were of it they to people tended if to experiencing it’s In to In overnight. see it going

see any treatment we to So don't tolerization effects.

it can’t accumulation people or to certainly side upfront generally are again, the take that have dosing seen pattern period. occurs We any last but as through to it. have effect, if So it worsening continue of going people not

Yasmeen Rahimi

far? how looking open then, dataset? cohort is And consistency so in the regards a of could So have right, patients, looking Are Bernard. of be quarter we you, XXX it just that helpful what how kind upcoming we very data you in us? us, Thank six this type that's at ahead should seeing, for patient follow this that Thank seen data I we quick just label just if expected remind versus for apologize, of catalyst, like from be you. could up orient upcoming to many be the we should this

Bernard Ravina

Yes. Thanks lot. a

so Part the then withdrawal. data first the milligrams. in from of presenting we'll to year, we'll next be open have randomized B, the dataset label with And the half of portion complete up So XXX

be aspect looking the Part focus there presenting will think that's saw data same is most placebo upper some we'll limb of from reliably We be A, So a measure. important really What of and we'll and on be kind the for comparator tremor. tremor most what the there. you with

and improvement of doses. was really seen What the check XX% small had very with to we us But that may XX ballpark a certainly meant in similar or very milligrams terms saw as safety see consistent, this cohort for out we overall titration in We higher than robust that like of what may just milligrams or XX looking in would the in what to XX%. a be In data, hands, are terms not of certainly we for that really in was over forward tremor enough move with. of on control this. more

Marcio Souza

And just expect. that numbers we to question add to part your about the then maybe of patient

mentioned hedge we're obvious to enroll We're that XX So we York. time like and to we on to in these I other cohort. New as results before, [ph], view about we about this. the a moving go the patients patients probably to talked back have December give in to we in discuss inform. including expect it's this probably get the might question, later going that to any data year Like XX program, of want comprehensive in the at that to we part point along just

excited We’re the we super XXX potential about have. and

Yasmeen Rahimi

Great. in to forward taking New Thank you so questions. seeing looking much my you We're York. for

Marcio Souza

Likewise.

Operator

Thank you.

comes question Securities. next Our Chico Wedbush from with Laura

is line open. Your

Laura Chico

study. Hi. I'll the remarks, Thanks opening much the I of you if missed be Acapella you XXX from about on the would assumptions kind apologize taking the outcome for here but Good morning, I this guys. One the Acapella? Thank more you. very powering for question stay could what question. And track. us and positive I in guess on a remind

Marcio Souza

to that the not and clear accuracy, not for I about past, be Acapella And maybe clear right. that. powered So want we're is in

different kind to FDA, in explore the with give program as dose the assumption that there. is did that's be side same X/X going registrational what agree is out they XX doing could we looking or similar we're per to a talked with might the we Acapella. lower but may lower to that's trial. a be of a that basically, effects. were And Phase Aria that trial. way going generates overview and assumption we this milligrams the there our than in When effects, the general day dose lower there us And So first And of PRAX-XXX

verification Obviously, dose-ranging trends like were using controls at place, X measures putting on. study. Phase of are all quality so in the eligibility, all a typical more So we in terms for looking of the and dose-ranging kind

or able be the should real, following to of we is that the that. data on up is So efficacy Aria trust But out year. coming I’d comes X/X that path say, the

Laura Chico

Marcio. Thanks,

Marcio Souza

course. Of

Operator

you. Thank

Minter next from Blair. comes Myles question Our with William

Your line open. is

Myles Minter

question. for taking the guys. Hi, Thanks

still faster what of XXX were sort you and the of sort that us the Just limited schedule there, upcoming relative whether for this nausea in study that rates in conducted, the titration frame you going X Phase are just to using and they titration were can faster you're you label you're titration EssentialX to the using titration Thanks. disclose? data And the open schedule X trial? Phase

Marcio Souza

over Hi, Myles. and to start I'll Bernard. I'll hand

XXX So the drug are to way the we about that part The the clinic, what’s this to are for for, to no, like of use, be, titration are up using question schedule. physicians not did blockbuster is the into and titration you terms going fast several expectation we [indiscernible] in planning a look be important that's when works of for the patient us. study shows of thinking look we is as ahead years how ask to why them? are fast going to And what is the type

age. and We're XX And in cohort up that safety. older we've fairly comparable study, to both able very XXX of You have cohort younger an a so years fast. than dose younger on seen and cohort to on older

we definitely that So check there. marks you can has all the wanted EssentialX started.

you As do our patients be trial. all accelerate parallel trial should to enrolled this but releases, clear do on we [indiscernible] program possible. from that know, much as press and in run that trying have have started we're and It as we

nicely. quite moving it's So

down new So slow for that the to we titration. don't expect

about I’ll come not over right little a might in the expect now. for hand to that back or general. we the initiate for we Bernard bit EssentialX to even Phase next that, but Now, X safety to profile talk year implement and

Bernard Ravina

titrated saw we similar Hi, original with fast to the really about titration Myles. where titration XXX-XXX saw at we study, what was we over The month. with the a safety profile very

us to up. don't they overall really a it then out. issues So seem we people start have to little they tend as have is they tells And before, when said that, as what titrate nausea, dizziness

Day Disorders same data So we'll titration. December, bit the are the those the at Movement in the unpack profiles or longer shorter the a but with looking overall more

getting picture higher at people big allow up was going to the get is how want quickly to to So it's or they need to for doses. Marcio flexibility

Myles Minter

Makes I'll Thanks. sense. hop the back in queue.

Marcio Souza

you. Thank

Operator

you. Thank follow Baral I up And with have with Ritu a Cowen.

open. is line Your

Ritu Baral

components up. the for especially to in wondering Hi, CAPS-X? not about woven know not I'm into I the just most there's rationale within follow of could Bernard, anxiety PTSD if sub-domains and anxiety to but How like XXX XXX taking talking others. think there's the and feel guys. Marcio various sub-domains wanted you the questions and I improve CAPS-X. you is there's Thanks -- PTSD, that certain I it's anxiety. domains, certain to certain move for sort were and the

Bernard Ravina

Yes. PTSD. We're excited really about

the in strong PAM, extrasynaptic for particularly given people benzos don't an preference, as GABAA part I think treatment work with actually avoid that of particularly [ph] them one a PTSD, well the is especially regimen. rationale of the and lot

those, GABA the really you on endogenous in correlates modulating get response rationale it good steroids, and overall data. There's And stress right, neuroactive experimental are and to the actually allopregnanolone allopregnanolone, reductions modulate and the symptoms. with axis. clinical So in like HPA involved in PTSD,

as as But scale. we're of depressive what It's there. the factors of items complicated dysphoria, the anxiety, many the and and terms that common terms avoidance, the different actually in is expecting CAPS-X across well across anhedonia. like worry features symptoms XX-item of in pretty cut to So see, cutting of are

particular any on study. We're focusing overall Phase at not X CAPS-X we're exploratory domain. so the looking [indiscernible] And

It I they're expect in domains we'll captured in up the CAPS-X kind cut score. will come So the benefit But learn see across the the will of and we'll particular overall as domains. show out.

kind range factor sleep. impairments to improved regular of insomnia different with might whole nightmares There sleep XXX. that are of be is from just other The there a in

learn broadly, we trial. looking we're from this but So expect to lot a

Ritu Baral

Got really And not the And trials prevalence it. for that is disorders disorder PTSD? are GABA? PTSD. used why? sort that the mentioned sleep you could contraindicate whatever any overall into And of of reason, is there You benzos what sleep might, within go of for

Marcio Souza

actually as it's well. incredibly and is Ritu, PTSD the Yes, prevalent, interesting

from clinicians We of is have MGH. company fellow one the our in a

there? the they our view, benzos the impact that it that I'll sleep to to disorders, depending closely really to anything sleep is into secondary, differentiator are problem forces, so fear, areas quite to asleep that? But about any would to this. okay looking mood time seems So conditions, on or [indiscernible] has. extinguishing or and program pretty condition we not able at. a us of add with like becomes don't like sleep preclinical just the of there, important pattern the you're you being the tired feel a dramatic in and for quite that versus not be ease specifically, be because models fellowship point a It condition the other even sleep that. here, has that's to huge right, time, the biggest it's to But feeling it's us. okay We it And this with Bernard, and the primary obviously, back time And versus rationale focus think about is And of [indiscernible] that all so go more that have patients on on something talking other on. right, when the when them having the for central Bernard changed we I at discuss mentioned always all

Bernard Ravina

to be for good different disruptions, would out the a maybe something, and sleep detail But terms the us of like sleep follow depression, in like of people Yes. very I’ll at Day. stress that more like that PTSD just comorbid do start say it actually break disorders depression, of perimenopausal more first conditions and kinds that in our disorders but if Psychiatry A lot of thing our on connection into kind common. it's think it's sleep that vulnerability. with up

Ritu Baral

up, for guys. it. Got taking Thanks follow the

Marcio Souza

Of course, anytime.

Operator

you. Thank

Our next question comes Bank Ahmad from with America. Tazeen of

line Your open. is

Tazeen Ahmad

Good in question part tranches. asked Hi. already this concerned, two releasing Thanks been going far question. you're as I'm essential morning. study data Marcio, if this before. as taking has the sorry for tremor to my of think I be is But

a year, move overall? And about forward expect data But data little bit bar going what be you what spoke for this your bigger expect Thank good release is You for see think you. enough I’m next should to to in we assuming to what's to what the additional quarter. totality?

Marcio Souza

Absolutely, and thanks Tazeen.

mentioned, look is when I'll it As of lot do So you down to there not Bernard done break we tremor in into expect? amplitudes. terms reduction more like what a be

effect Of course, on there the is a floor Tetris.

or So are XX% the few in that be I for that's to going XX could that think would the were that or the if before, up And patients months. so look be next into more showing had you when we that you that next like outstanding. there great on ballpark,

and what a the like number looking be things, For of next earlier year, we're right, year. would this in for,

like complete point Phase And been part come phase biomarkers, to patients that's activities also is up. we've time, and a patients that to we trial, that some quite exploring to the of blinded, measuring, want X talk and that why many that one a of trial well that longer wait importantly, beginning like going datasets, program. to wrap more so the digital That as we're that's different like little the have bit of year. requires is to little it and that how like at how the treatment some randomized why back daily of type more withdrawal the showing a right? that much doing and the that be discontinuation, bit little as we're living completed baseline bit enable we And after about biomarkers, So in work, the would need

fundamental coming some say, the modulated brain the Our I hypothesis more in are being oscillations going going slow going to again, is change essential network fundamental that tremor. tremors, our to hypothesis by be But because is simply that it's terms like the how in treatment may wired. there's primordial relatively back, of a reducing for is

constant be this So state we explore that's trial. trying it might were a create on more actually that of production, why we and to

is explore to is typical that separating one design, trial. on first hope be how the the able the able for to of two we we wouldn't they second quarter But and see we quarter be the separation parallel that learnings. much now the year, we we’re a XXX year, to should be call first and the see they in we and the for terms first see that second to half -- EssentialX a nice so or beginning more EssentialX, the the XXX, of do much but name sake patients, these this patient able of should there. return. in used to The we and And why And return of do expect that's

Bernard Ravina

point is mentioned, saw XX propranolol. on were was in we XX% people the at which roughly that I’ll just Most echo taking Marcio reduction milligrams, that A cohort top.

on in So come it's the in we've impossible because been [ph] where one get key medication. the mostly people But studying this visible. point is floor effect adjunctive. almost allows to tremor to below a one the It Tetris is other barely

have or thing is do rates. really doses, a the have tremor up But responder basically can So you'd only go on you make basis, patient-by-patient you go in maybe to higher away. invisible

run into effects better they you of So have measure unless a floor these tremor.

Tazeen Ahmad

Okay, that's Thank helpful. you.

Marcio Souza

course. Of

Operator

up have Minter follow with with I Blair. William Myles And you. Thank a

open. is line Your

Myles Minter

Hi, Thanks the guys. Yes. follow for taking up.

two more don't been I've like, study disclosure a that just PTSD a rationale see if XX patients just XX could great? the flexed this, I for CAPS-X mg, improve would the design, dose mg of getting have arm? the a on questions separate perimenopause sedation weeks X what patients rationale XX patients at it Phase run doing given the on like versus just we'd the for through was that running depression of be on the XXX mg over me potentially for few think Just to or you

Marcio Souza

there, the Myles. I'll last with Yes, of start your part question

using a in lot So of that is gets. that we're exposure right tighter the formulation it terms now the

much to don't expect variability have we So there.

XX and So that gives us a nice XX. separation between

varied on seeing previous formulation. [ph], the as before really we loss much not we're So discussed

one. that's So

looking The to drive first what to we're second is the [indiscernible]. one,

move keep So But then we gives the probably of kind much We much need brains bodies look explore exposures do understanding. the PAM -- to patient PTSD go And into we not we actual in will us to like would go run there. way discretion XX. how that possible the would going it up expect best how did we would like domain, space. the need? understand. and in to under their the action, And this that gives most sure and XX% or patients that. extra after the all why that's tolerate for of got to we GABAA in we're the on an would few the within docks want make Then for weeks CAPS-X we either off if ones we their for that's the being that well they up or allow what the would the to open or a plan they're to thought And as label [indiscernible] not after It so planned. sites have [ph] from patients right of feedback a [indiscernible] more these on going that

to being to the path understand with have going our exposure afterwards. this population FDA the we're So what a hopefully and able response, like discuss will registrational safety very look nice on

Myles Minter

Thanks.

Operator

further to over back questions in I'm for any at time, queue. Marcio you. Thank no comments. to showing And this conference the the I'd closing hand like

Marcio Souza

all at we that for lot of that And there a the lot questions. and much so to the joining again share everyone of thanks quite and Praxis, pleased the behalf on for you progress. work here was we're Thank and a today was to and reviewed team

in other on As portfolio through to early the concepts. you ASO advanced year saw, as stage. virtually to here therapies to surpassed next personnel, be sitting to a every our And work Bernard In so full is for since nicely, the we caring for of and every of on than thankfully. trajectory ASOs and the quite But the in And and funding in very in along we’ve all and just that having doubt company Boston. come, steep here you our -- More weather time we Tim that. to well, last the to we the of with the all we that's we how our near bringing next a fellow year, as program these a for we few tag practical we're all manner, company, a right proof clinic say advanced right, We're us. and patients. discussed, whatsoever no in us Boston as we continue wanted to day to there efficient like more first new the one was to a have are to necessary we deliver that on Praxans finally, everything in headquarters [ph] in just we beautiful We XXX of them have to the Dare public proud future. me forward the to colleagues number along we going exciting our basically a in like of year always number In employees this doubled months need. lot patients come moved look busy growth last and We call deliver super months. as far XX

So day. for enjoy the and thanks again the of rest the support

Operator

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

You have Everyone, wonderful may now disconnect. a day.

Praxis Precision Medicines (PRAX) 7 Nov 212021 Q3 Earnings call transcript