Dr. Bill Sheridan
attacks and available on going the therapy first for inhibitor kallikrein of acute plasma of attacks. would that program, our I’m lead oral treatment focus HAE Jon. HAE a targeted Thanks, to be today both BCXXXXX, prevention
We are across making of progress aspects all program. our excellent
study, the ZENITH-X Our APeX-S to on prophylaxis APeX-X for trial, safety label open remain the track exploratory X the acute Phase treatment. and Phase timelines X trial
completed report of this this for one to and data We have trial later enrollment expect part ZENITH-X patient in quarter.
that we for by PK left of the profiles data range could diversity in with target in than milligrams acute more XXX was the attacks levels on-demand X X Phase Clinical treatment in angioedema had this two not With advance. required on to suggested the hours XX The trials approach XXX range readout, dose, registration milligrams. slide These of of when milligrams we in two, from XXXX one, XXX have and to unique of we in identify was information, type when drug to looks the rescue using all outcome to a on to as Other some setting hours six. durations therapeutic rescue rescue trials our first wanted single of of range, test, volunteers that prior are of levels the the the panel single As a were exceeded to according of symptoms attack to possible the construct protocol. dose in at-home, of against Phase The self-administered, These the comparisons used of acute notion endpoints healthy targeted are and meaningful therapy identify the trial the and selected in established doses profiles and an levels, treatment treatments then how exploratory shown the about features depicted make slide the are early injectables, and the trial. principal in relevant X what use XXX it and today of prophylaxis of features shown including panel are trial; line is are the trials you treatment available intervention. that variation at doses want we here dose The in that injectable success in profiles include treatment subjects. worth HAE dose HAE The the this were PK ZENITH-X. them. dose its of been at tested review like context hand trials, licensing care. in trials given the additional duration that this not the in panel. of period these The yet the of Over results takeaway the milligrams goals because middle simulated done standard clinic. treatment and and noting to to treatment activity clinically some approach measures, really simulations long the an prior as to in acute valid between marketed treatment is right in of at to different with to endpoints is we the we that currently X,XXX to be both shown achieved seven,
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So, nor the patient, neither knows, the investigator which are receiving. they
least before for Importantly, hours This to reaching see at wait to four treatment risk in medication. we provides effect. a ask patients any an opportunity
rescue needed. Of course, at patients time see do to the is any what reach option they have for medication
There data throughout monitoring an clinically been aspects We for registration smoothly. moment What HAE on the maximize trial. very XXXX. the we most to then the operational discuss later selected study Lynne forward do identify to conducts of results big trial the and against this is well take ways basis results endpoints and until subsequent of these forward won’t, trial. first will prevention to the some the meaningful, cannot commercial meaningful endpoints a one assist been these is to our the endpoints for have going of these market. want The clinically multiple program registration In run quarter in exploratory and have and efficacy study our one Which on a endpoints to on are meaningful of the reporting translate ZENITH-X win update more aspects and APeX you of attacks. the ability We results. regulators will beauty the we play acute a proceeded have to We design here. and to patients study. determined or as in But of subsequently of full opportunity I blinded which role But, matters also can of when endpoints a the unblinding physicians then. be interpreting experiments the will the look half share of
peer were of As that of successful we X Journal called weeks two the our of and Phase in just published for trial know, attacks APeX-X, New a we HAE completed reviewed many was Medicine. England ago honored you prophylaxis
data recognized Designation advance with Promising designation by XXXX. APeX-X APeX-X have an Innovative UK very XXXX well enrollment could strong and the We daily remain care provides and of proceed authorities represent Medicine track by XX-week U.S. the for APeX-X continues the report to MHRA. second highlights believe and of Track quarter foundation in potential medical the for the FDA to the that prophylaxis. that regulatory oral therapy value addition, on in In Fast we once
we to with call of are Lynne our From open to long-term I’d patients who commercial the the turn standpoint, and APeX-S have urgent therapy represents a clinical study. both markets. physicians label a prophylactic an the like perspectives We safety some of now and acute over around also share that pleased believe differentiated that XXXX progress will need for. highly the
