the wellbeing their you, issued good clinicians March today. and first, afternoon in Thank Jodi, and patients to of involved well pandemic. the COVID-XX safety put as and employees trials, us and our to clinical outlining continues you everyone the a our all families. we joining including end thank Xenon statement response and the for our people At of
weather economic objectives to We are fortunate have that this runway our crisis. the to support cash unprecedented and health and business we
Despite the several the proprietary of the each our I'm and next to over pipeline anticipate clinical partnered of programs. COVID-XX we our I'll progress global both status as on last our months. Today programs a our events pleased quarter, impacts milestone on and innovative stage from provide pandemic, well treatments update the in of as regulatory report clinical neurology products, epilepsy and over important XX partnered exciting
KvX with and epilepsy potassium being the is other focal I'll differentiated potentially XENXXXX, a start for treatment adult next-generation which disorders. of channel developed modulator neurological
compared treatment seizure placebo. in from active approximately adjunctive the tolerability safety Phase The median multicenter frequency as the currently and treatment administered XENXXXX period study baseline the the to adult versus patients endpoint Europe. Canada underway Xb in States, trial XENXXXX double-blind, change trial efficacy, monthly focal our with XXX United for epilepsy. clinical clinical in to of is is placebo-controlled randomized, primary a The focal and enrollment percent evaluate Patient is of
and the tolerability X-TOLE been of been to safety, trial, tolerated treated. assist XENXXXX blinded discontinuations what we and have from discontinuations has to review well patients rate To-date are order continue in modeled. who from data this In study was below the
of of the open-label than to-date the from XX% In rolled-over addition, into have portion double-blind the trial subjects extension more phase.
analysis safety an a have analysis Therefore, of data based the required. is on we do we blinded not that to-date, decision believe made interim
here. a than lower the was allowed or have modeled, reminder, the changes As of which tolerability groups other to this is re-sizing different if option for would study dose not for case
taking context their relate the Europe, with randomization. its close on in clinical guidelines North collaboration patient new impacts direction sites America to of we In in and are clinical ongoing XENXXXX from respective of clinical studies, pandemic, the they screening specific each and COVID-XX the as and
to in remain any that focused data in to patients in enrolled study, portion currently provisions drug integrity making the minimizing on or efforts making the supplies either for patient and ensure double-blind the other possible, portion in-person patients the of amendments study, the including adequate is wherever open-label in while extension maintained. study, visits necessary Our
also as to individual as to soon jurisdictions, patient taking as both trial sites to clinical step deem expand do enhanced to sites well new the existing support are X-TOLE trial We in the so. new clinical it the as safe include screening
continue base will and believe coming the We We some pick sites are screening this over clinical entering being and resume patient seeing to up line months. patients randomized.
the first which pandemic. the XXXX, Top upon sites half impacted clinical the dependent enrollment be in may feedback from COVID-XX anticipated patient line is and by data rates, of
to more to over months. the potential mechanism also X unique going and its coming with action, of outside trial Phase we as of concept for explore into develop look epilepsy, detail plans proof continue a of XENXXXX these indications Given we forward
that reformulated recent for first daily products, sites KvX developmental as neurodevelopmental characterized a active KCNQX the seizures know KCNQX-DEE, and is as our one in contains the ezogabine within ingredient no or incidence approximately have disorder medicine a refractory pediatric developing multiple condition live XX,XXX which at within XENXXX approved Most has a by the severe epileptic also a and encephalopathy epilepsy pediatric pharmaceutical potassium life. propriety called births. which of for epidemiological treatment presenting rare that of are been channel is retigabine, we portfolio Also modulator and week
There as is in to by well cognition anecdotal surveys rationale supported which improve clinical population. with as and and burden further treatment feedback. development suggest reports rare These tolerated maybe that as is non-controlled well a physician efficacious a suggest may maybe parental and pediatric XENXXX genetic case for potential this to seizure strong reduce ezogabine and data KCNQX-DEE,
XENXXX Designation seizures the has also related to FDA Drug treatment the quarter Orphan we designation of Fast The Track and first grated investigation granted for for of the KCNQX-DEE. were in
months in I’ll which progress you. outline our XENXXX we Over the made considerable past program for few have
our pediatric support Phase First, volunteers. KCNQX-DEE, formulation adult complemented of trial XX healthy with to PK X in proprietary we a recently or planned clinical patients XENXXX pharmacokinetic study testing a in
Subjects were state. XXX fasted the dose single given of a in mg or fed XENXXX the either
study not and to determine showing plans tablets, ezogabine Phase historical comparator, is given to be comparable profile PK XENXXX to PK supports the the not curves. designed elimination data as and our bioequivalence use While XENXXX similar absorption with available for a ezogabine appears to X was observed for immediate-release
a second single path and additional Second to and recently Phase the have X clear a for received study we FDA to we the XENXXX, now related importantly, feedback program interaction from initiate year. our with Phase confident X are we this
efficacy, the of old. clinical clinical years it acceptable the anticipate trial long entirety also side to effects we pediatric study XENXXX the evaluate acceptable KCNQX-DEE. X that and Based follow-up infants placebo-controlled to the Phase children up potential plans, a to of to feedback, including in Our proposed term six tolerability initiating who safety FDA, indicated on monitoring were to is in FDAs XENXXX randomized, safety with double-blind, patients and monitor
patents addition. be is will either of baseline treatment an is frequency of post-treatment extension that randomized then by seizures, versus of maintenance period is and The in base to treatment Off to It placebo. anticipated endpoint percent assess the period expected change screening, period up or in XX after the compared label a frequency the placebo. approximately primary titration in will a period the an period. then double-blind active median It group trial manner initial expected line be blinded treatment patients followed that active and be seizure to open follow a portion a there from will enter to the
now as also the well for preparation trial, CRO a Dr. Phase the site principal Global as well the X have and selection John we selected investigator study with we’ve In Committee, for made Steering the Millichap, underway.
the In for team XENXXX. addition, is U.S. of clinical submissions clinical support broader to of development outside our planning the regulatory development
We expect in initiate the and mid-year around Phase year to trial protocol X as clinical previously our this XENXXX guided XXXX. X Phase submit
KCNQX-DEE. first study of the kind is this believe ever We in its
precision first using with include will and experience one the monogenic and The some as infants medicine the the this age, pharmacology as first trial a month young treatment population. patient time of in epilepsy monogenic known drive prior in epilepsy
where we from to to impact COVID-XX. to eager needs medical FDA, significant and the initiating disorder, the other foresee feedback exists. highly we high than in We Phase potential treat any still XXXX, trial recent bring find exciting the juncture are do hard therefore hurdles at a the of neurological With not an ourselves and X motivated to severe innovation and
We is Conference. the its the are platform using presenting in Academy which virtual of program poster XENXXX lieu of by this presentations Neurology, XE to hosted American related Annual
the PK PK and the recent summarizes The food study, effect first poster our results XENXXX. examining from
in website, posters as of survey of virtual well three patients video encourage you examines Xenon online KCNQX-DEE; of results The for patients to the literature the versus EEG video platform, seizures diaries second as been summarizes with with them. these use the poster review of caregivers to survey All I third added or evaluate poster to so our counting and the KCNQX-DEE. have AAN and electroencephalogram
with ingredient well CNS-acting XENXXX modulator T-type modulates channel to as as calcium This now flunarizine. Turning active CavX.X, is that calcium the a channels.
label examining efficacy, failed and absence physician-led in who as standard treatment events. of clinical epilepsy. care in childhood because is anticipated adverse reminder, that will diagnosed patients efficacy manner, It XENXXX of to enroll treatment-resistant an with have an the now study ongoing CAE a of the XX potential approximately pediatric patients tolerability adjunctive of of or proof-of-concept open As patients is lack because with study safety
CAE potential development this Phase analysis our X ongoing from pandemic. the a XXXX, results study, orphan course Results given in the from may enrollment for the expected represent on rates of dependent COVID-XX Depending upon future of indication XENXXX. study final of are patient
I as pre-clinical turning pipeline to it early build also early of We matures. channel robust Before programs, this partnered targets. work upon note potassium our of look forward encompassing candidates, exciting related preclinical efforts and novel a and continue discovery number work to stage stage to our sodium that highlighting should our our drug to
NavX.X of and the sodium DEE for indicated We the treatments now has X encephalopathy Neurocrine application Phase clinical other has this Biosciences it FDA an second known start patients to develop mid-XXXX have developmental or inhibitor forms epilepsy. order that exclusive an a selective epilepsy. potential in with channel anticipates an to with XENXXX, a NBI-XXXXXX, Neurocrine in year. ongoing SCNXA of epileptic to trial Neurocrine license in SCNXA-DEE and in with stage half as clinical IND filing SCNXA in Biosciences collaboration
milestone NBI-XXXXXX IND for upon important of This $XX would milestone in acceptance amount to the million Xenon payment Xenon. an equity form investment that a with of FDA in an XX% the trigger of
website. posted our have also and in of caregivers SCNXA-DEE to be These conducted Xenon on survey the the the clinical will collaboration Prior presented days an that e-poster patients. on a with AAN Xenon team Neurocrine, summarized virtual platform been of
In addition, both affect One adult pharmacokinetic assessment XENXXX. we tablets to and representing release two of summarizes posters food granules immediate NBI-XXXXXX. XENXXX two relative of including are the pediatric and bioavailability, other relating formulations, or
of non-selective adult assessment regarding The or co-administration pharmacokinetic for of of providing subjects and healthy interactions XENXXX drugs provides NBI-XXXXXX. other XENXXX sodium of safety an channel with summarizes with and the information the trials Phenytoin, useful a a between future clinical blocker pharmacodynamic study XENXXX and XX with intention the potential
from The Flexion our FXXXX support product to of initial a to for as is and XENXXX FXXXX now thermo-sensitive NavX.X with a FXXXX and control of Moving we preclinical to acquired known inhibitor. Flexion's block intended Therapeutics, extended-release rights as hydrogel. for develop commercialize formulated partnership peripheral of postoperative candidate nerve administration the global development consists pain.
placebo. presented showed website Acute new effect provided an no Flexion with of on motor presentation April and that function impairment analgesic and American year this in to Society liposomal of Anesthesia compared in e-poster the data FXXXX sustained, Pain Regional animal post-operative In bupivacaine
controlled at of local FXXXX triggered the high and providing in active addition, anticipates ingredient site program. measured In with in the to a XXXX concentrations the the clinical creation this duration depot the XENXXX, exciting of study, we were tox $XXX,XXX partnered in The is of human consistent forward GLP administration drug on look release. a us Flexion for a which with of milestone start April. of updating study you trials payment to FXXXX, initiating
the I'm currently ways much so has and through adapt COVID-XX the in we to what strive support proud on health patients focused Xenon other stay believe exciting as one public to development and continue the we to to of pipeline in to to work therapies be bring Xenon we epilepsy novel crisis. team our new and need. most needed find
workplace. employees also near of are contact that back the in businesses will close includes COVID-XX medium to workplace we the assist be during could leading great initiatives our showing the We transitioning community future term COVID leadership in believe positive and face employees likely that numerous or a pandemic, what managing
and Ian up to before provide call your Ian. this point, ask questions. I’ll financial recap closing some our the commentary As position to to opening