strong progress in initiated call to We're the planned making this our new programs, underway either you Robert everyone we're I you each want or of joining fiscal thank to Thank today. today key to clinical really clinical which for on year. be three excited update have the trials on and
to development drug may regulatory the opportunity the of costly regulatory compounds for less Section a marketed FDA's well-understood and to risky, and is and improve reminder a therefore the and utilize profiles leverage pathway potentially The provides orphan efficacy exists. unmet As provide candidates to to our shorter, us technologies for novel marketed drugs a significant our path for strategy of approval. delivery safety these XXXbX where less company's drug formulation need the indications
diseases met point to also often require from experience that specific FDA for the served within clinical with drug and drug safety if not and might some and FDA studies approval. of populations are realize diseases or case may certain patients in Section the children one and track by current through All exclusivity received clinical otherwise conduct preclinical smaller, under targeted to eliminate to provided trials efficacy patient the each considered to drug commercial therapies those It's sufficient evidence product's of These Europe. market the has with Orphan marketing GTXXXX potential. seven much require. post-launch in previous approved XX literature infrastructure the these conditions years a and the a three example potential out important therapies fast yet be of fewer although well-understood, of are and new typically sufficiently targeted States of provides available designation familiar orphan they exists our poorly Acasti or candidates that need drug ataxia-telangiectasia for by for have in drug not of the United candidates scientific may for the years for review involve our already and exist. rare development XXXbX, the For do either more designation exclusivity remain drug
novel no indications life Our attractive the opportunities the believe by debilitating versions these Section diseases the competition. and little XXX(b)(X) patient for the effectively that underlying symptoms treat us pathway drugs to result with with our these disease or of ultimate of goal is with improving reformulated quality provides leveraging outcomes. development in orphan of aim from regulatory of We highly
status ongoing update So quick our give of with on then background, drug and efforts. a lead of me let overview provide candidate GTXXXX clinical that you as our the a I'll an
is continuous a a innovation XX% the patient to which infusion in bleeding new patients subarachnoid hemorrhage over the a nimodipine hospital so little ultimately reminder, one-third vital patients to emergency seen with addresses critical via them a of novel is proprietary aneurysm. die condition is IV or The a that survive. drug a of years. for the designed formulation reaching ruptured intravenous SAH that's in care and last critical caused the administered do formulation before about our XX% condition to SAH, for brain not ever presents XX of by SAH specifically life-threatening and be due need the GTXXXX a As market in
of awake lives. is these in dependent a on based is for require one-third as as is conscious a per million. called is their problematic we estimated an they're administered affect the capsule liquid patients not have the channel of SAH research, SAH due drug. patient US in the is Furthermore, in oral if or alone. XX,XXX a of the available food represents about orally as patients control it brain these or only administered well to brain blood as making can to are States as and $XXX the And many Another that rest pressure market they patients levels nimodipine orally of GTXXXX the blood subject to resulting care hard patient. the solution, to the which more leads which in nimodipine drug feelings. United in into is which large of tube in a which enhance blood variation must an an believe effect to blood than year three variations to the swallowing inside in flow, stick was drugs. the US difficult weeks can the delivered current four to oral in of function in dosing affect addressable Nimodipine the of of the changes total hepatic nasogastric blocker time hospital that a drug via oxygenated care often FDA The be nimodipine standard the be blood of course of the to market lot to by can given which and entire Nimodipine diurnal time pressure up tube, the weeks. over is throughout XXXX. flow all vessels caused remains absorption relaxes Nimodipine a way approved back that by Consequently, day allow lowers more potent a oral renal variability to a calcium blood typically the metabolism XX-hour our
that precise GTXXXX deliver updates GTXXXX. way patient's into share as intravenously rapidly convenient that So delivered directly a for advancing to SAH more for nimodipine changer clinical on bloodstream. the could efficient me we let overview, be a the and patients believe program brief with With game the latest
bioequivalent our of results that itβs safety intravenously no the objective last to that call, met our considered nimodipine conference pharmacokinetic announced to successfully between assess we intravenously oral to tolerability. The the The serious delivered observed. May be was male study essentially can statistically compared in points. healthy meant on was and total XX This bridging exposure on objective and maximum the discussed nimodipine primary had GTXXXX no end study secondary and were formulation of oral GTXXXX relative administered we and GTXXXX the all female GTXXXX of difference As showed in evaluate adult and of oral events the nimodipine. its bioavailability to adverse while subjects,
to inter and subject that blood levels, and the also oral as lower treatment for physicians And results are submit can much because incidence variability its with for Type results. our hypotensive GTXXXX get recommending reliable the a Importantly, reduce patients could FDA's regimen immediate intra provide outcomes compared and more FDA C could may to to better which was plan request consistent of believe and costly with now profile guidance excellent the calendar a We to events Phase more bridging for PK QX. require the with GTXXXX nimodipine. GTXXXX we vasospasm This worse and be we absorption study plan effective a key X of help more meeting as to the study SAH. PK our the advantage for dosing on based in to on that PK lead We intervention and patient. recent final safety our
the a their want response for X obtain with review guidance and the safety them provide for our following meeting There's FDA request also and study time the comments. for FDA to We before proposed Phase study. the their initiating to to design feedback our XX-day
or So early we in XXXX. very expect calendar the FDA's feedback the would this to of year at the by end latest have
of the the the I'll and safety to or for to oral X XXXX. GTX-XXX objective major we result, study future we to nimodipine, of safety that a worse study is first than marketing purposes. Phase X additional compared to our is patients publication calendar everyone profile As remind collect while oral to that SAH expect want start the Phase our in show our no of pharmacoeconomic data similar also half in
discussions to meeting C before with patient program's each in guidance of collect the drug as important oral such the the opinion plan key be the and leaders, Also, likelihood with in we our on for intensity time And of events administration, so form to Therefore, will increase and of for and the follow-up study data associated GTX-XXX a compared stay the success. amount input and will based of ICU the number nimodipine. drug starting FDA's important. effect hypotensive risk we on. having and So we're length advance reduce the for net getting obtaining the ultimately Type the really their that in of regulatory believe nursing
Phase expected the clinical to to safety treatment regulatory X about patients. approval study SAH opportunity the SAH. this to option to the submitting required a to We're the extremely new bring new As everyone, with regulatory is GTX-XXX to seek before the excited patients step pathway, be application final FDA XXX(b)(X) for treat reminder to a drug under
spray are research transition in lung has States, conveniently sprayed found affects start improve therapies. of mucosal of the a potential study of comprised per Patients typically cancer. reminder X,XXX infections swallowing. symptoms complications impairment and ataxia-telangiectasia a to approximately of about immune system, die is of novel concentrated of of patients to or brief the let primarily is or A-T by me often to betamethasone Acasti their difficulty is disability, neurological year a concentrated disease in that which the novel now can total A-T the a market affects disorder children mid-XXs susceptibility A formulation United A-T, from a Again, program the as market the progressive and commissioned in gluco-corticosteroid and intended $XXX betamethasone, number a for of estimated million, that patients. have treatable GTX-XXX over I'll GTX-XXX genetic on currently an overview. that oral who the neurodegenerative A-T patient, with tongue severe be causing So cancer. FDA-approved of no there young increasing GTX-XXX, based addressable
bridging to the and treatments forms different betamethasone which GTX-XXX measures product crossover oral the total the of PK IM solution oral to product female of an And spray. for I'm in in different schedule GTX-XXX evaluate single-center comparative injectable, male to study open-label will five study the and male purposes. we purposes of remain IM oral safety study would in to plan three pharmacokinetics, doses administered intramuscular filing So study and the We This injection reference be betamethasone report of bioavailability, betamethasone and betamethasone, will and quarter be conducted oral to compare to design. and on a of to levels study be initiate pleased XXXX. is it including in we'll of the in will for This And will comparing in that, betamethasone, a the US be compared female GTX-XXX of of GTX-XXX also adult Blood randomized in subjects, study to which third and this healthy be a filing subjects XX as treatment study, reference the compare an safety enrolled crossover healthy Europe. solution. an Canada.
earlier, As XXXX XXXX. mentioned PK to our plan this bridging the we top the quarter study initiate record we before and calendar I third expect to end of line in results of
the like, B studies GTX-XXX, the to under X meets expected X confirm safety calendar Phase Phase to GTX-XXX endpoint, its with for for would plan to If the primary GTX-XXX of study NDA design. follow. second Type to Section bridging of And filing and in conduct a study PK following patients. Phase study The the half we XXX(b)(X) their Assuming initiated A-T is endpoints in the request efficacy we meeting PK FDA, trial Phase XXXX. plan a of X or be end an completion study the X meet primary both
in sprayed GTX-XXX patients suggest the that a that to often And following GTX-XXX the lidocaine thin which PHN. and or film, and pain on that GTX-XXX Approximately out XX% randomized and important in evaluate quarter only novel, a the four relief. non-opioid, nerve from the the the It's confirmed standard XX may unpleasant the study our reference study, effects, We tolerability gabapentin pharmacokinetics form the XXXX. conveniently for study GTX-XXX pain this of safety as topical a PK well pain objective of prescribed on Okay. study pig injectable our could discuss also based onset applied suffer bridging point the need pharmacodynamics, of spray. characteristic shingles on And in persist market side mini patients sensitivity to of a levels and relief. to be nice and insufficient abuse unmet potential. application form our healthy July although pain single-dose the the skin, the to finally initiated in with compared has of single sustained has inherent Phase dosing of from of we the bupivacaine second ingredient topical a analgesic lidocaine, and subjects. healthy debilitating the disruptive pharmacokinetics completed a PHN subcutaneous care, need is let we X designed cohort Canada. experienced Canada, potential form Health a non-objection to proportionality, XX/X duration parallel profile initiation dose, followed action, the study, on the exists topical The GTX-XXX to patients planned as And the primary severe of on injectable of is wherever that's of evaluate the clinical treat therapy, of be GTX-XXX, bupivacaine, as faster PK and compared this is of of The has single spray The located. once day, oral trials. to made me bio-adhesive, need to our in the significant a studies dose of who listed for nonnarcotics versus metered include an will as treating for is dose active are a that patches from bupivacaine, includes XXth, spray, a FDA, letter our designed benefits assess study pain. progress GTX-XXX feedback given the longer believe via relative bupivacaine twice a more dose being can drug And may three debilitating need protocol -- relief which infection. GTX-XXX believe be The PHN schedule bioavailability to We to intramuscular be of gabapentin of pain bupivacaine subjects. pharmacokinetic skin can
cohorts will subjects four the enroll cohort. dosage subjects study the subcutaneous to different will in in one, at levels XX single XX per subjects, control. a three three GTX-XXX mentioned, and injection, active two will As receive Subjects up of and respectively receive with cohort
study sensitivity, design pharmacodynamic is important skin to on The healthy team. and for be calendar next for XXX(b)(X) This assessment to by schedule GTX-XXX, accomplishment the for study followed dose to regulatory our dose be X far on of information frequency by conducted patients. on will the a of yet of in GTX-XXX be pathway PK Phase another XXXX. by collect addition, which the volunteers guide will sensation important In and this in development. The provide study year, ascending performed PHN study dosing will GTX-XXX, is dose information proposed measuring and advancing further planned XXXX, end human it's single so the completed results our to achieved early step quickly GTX-XXX Acasti guide expected multiple the our initiation clinical for in efficacy next decisions in and
quick call QX the turn our numbers. over I before review quickly, for recap to of me a let So Brian,
all first planning X is in planning GTX-XXX for we're of and underway of the XXXX study the Phase now. First, half initiate to a
feedback a be FDA, Phase X design the C we'll dosing obtain study to support approved. additional based confirm our to agency's and PK the would on efforts excellent study with marketing that meeting like the on product to once mentioned, requesting and As commercialization we help also before is results and our to pharmacoeconomic collect, which the data final could the Type initiating regimen, the
X obtaining the month the ultimately that GTX-XXX, clinical the later and net top and start bridging benefit XXXX, originally will or from commercial risk opportunity, planned guidance quarter we our of success. before to of we the We study for now regulatory as of believe While effect report PK and two calendar to means of reduces out third planned, a our this this and end FDA program's remain clarification to in Phase than will the schedule initiate on continue line trial expect the calendar XXXX. results
will efficiencies to In important I Assuming well compared think XXXX it's the and X and by to will point focus of multiple that in identified Brian on additional guidance, as on and in efficacy schedule we've patients. to Phase our expected cash, subjects. out dosing also that And a on human meets PHN as to GTX-XXX, the reference study our important is design end plan in implemented July, moment, healthy conduct a study managing as study, primary dose the in while will expand ascending X to endpoint Phase operating the patients trial calendar GTX-XXX planned, listed XX fund, half and and second given bridging provide the of be capital healthy to volunteers, will tightly the continued study, calendar dose And based this PK humans the XXXX. frequency and have we least of This PK its it through that the our we study of value continue additional This initiated of to sufficient inflection in bridging drug support safety March in evaluate through the FDA's XX GTX-XXX operations of we XXX XX bioavailability on our single-dose on XXXX. of bupivacaine guide advancement X and key completed we across important now points. Phase in months the organization. capital information believe to relative at
forward about our towards excited year. company progress in very ahead we're prospects the line, the to this of milestones for keeping I apprised look bottom you fiscal many our So new and
your Now, our conclusion I'd our like to turn to to call questions. of open results. review the the financial Ford, CFO, call for the we'll Brian's remarks, Brian? At Brian over