to provide a dry Thank and is new opportunity and a you update of have important milestones. powder update you busy data the a Verona on Today's focus with pleasure formulation today. will clinical business Pharma to number a It's very with development year clinical for value-creating ensifentrine. the Stephanie. naturally with XXXX exciting of the
U.S. or and RPLXXX, ensifentrine, first-in-class to symptoms is which function, quality class of first decline existing dual in called in the with improve reduce therapy. function, life respiratory will effects patients we number anti-inflammatory differentiated the and that potential one produce the and who boost unique patients and as and believe used in As it bronchodilator globally. be COPD therapy to potential large in remain bronchodilator lung activities care a Ensifentrine in COPD truly the for the in of on bronchodilation being and medications importantly of both be the symptomatic a of standard sustained and of maximum with of a years it's that and moderate-to-severe anti-inflammatory the PDEX We from despite lung first diseases combines compound. has millions all novel reminder, PDEX the XX inhibitor, believe over to has treatment
also dry data with with First positive a Phase happy of announced a all, that powder the share Relations to PDF the posted Events DPI, more I some that am formulation of II we on or inhaler, around details ensifentrine very COPD section very our you was as will as referencing I slides were be yesterday. website, Investor of page Stephanie In conjunction with the my to comments, the of mentioning.
the study was principal was encouraged in an by Carolina, the at Research Joseph to by his Union very remarks meet for the potential provide pulmonary U.S. and patients ensifentrine's The mechanism South III, "This MD from improvement the and treatments I investigator conducted need and action with progressive function of VitaLink and He unique the lung press physician urgent new for Boscia this debilitating and quote release, disease." highlights for clinical data
the dry details DPI In days and crossover this all randomized, Phase the secondary seven formulation II placebo-controlled provided efficacy moderate-to-severe daily COPD PDF. study lung of met this XX well-tolerated patients, function all attached ensifentrine a and were slide doses. evaluating novel at powder primary the This study study, and formulation of with drug in tolerability of are and dosing a for was double-blind, of endpoints was twice in three
forced with This measure as heard with a the of And was you endpoint X peak of As you XXX, of was by volume reported one actually data There the function we studies or less positive highly now during bronchodilator microgram. recall, part for study can efficacy hours primary all also dosing, on four substantial study formulation. part year. early from was March this safety exhaled you single call have four. previous we FEVX volume, clinically X,XXX improvement in X.XXXX dose first the in as taken day a and seven day on of endpoint of lung of second on standard is of response see have the in expiratory may it this we doses, breath course, of first and P-value in slide, a as statistically before as nebulizer the slide the measured and the The than seven. significant observed X,XXX XXX, meaningful
dose-dependent in improvement lung function. Importantly, the demonstrate data does the
to the interval and on dry interval six, the last be of that similar was slide nebulizer see FEVX other in and daily very slide the twice a profile with an data formulation slides you the five for statements suitable with at seven, during can on day last on good XX-hour on clearly X. doses power effect day you all and the XX-hour dosing with event average a again, profile safety together a on placebo adverse some the tested also and The seven, dosing. well-tolerated durability Once day, the the to demonstrates trough ensifentrine is ensifentrine ensifentrine very shown see during dosing consistent studies of
a addition of COPD. evaluate inhaler, to safety trial, part and data a dose-ranging pharmacokinetic second and part, design formulation, next crossover inhaler, In at profile, in now is to first conducting two-part a this from PK with of reporting efficacy patients delivered single anticipate a the dose we with so DPI trial of or the MDI trial The in are trial Phase the and II MDI by moderate-to-severe XXXX metered-dose ensifentrine placebo-controlled this we year. and design, half data in randomized, of the double-blind, first quarter final the
via potential This supporting be device. data would delivered powder a have handheld ensifentrine's to formulation prototype dry
and/or COPD inhaler COPD of the with of is to devices there drugs were expand devices matter, availability MDI As there use in of to in prefer MDI approximately could formats the for XXXX. use of in in and five devices. use U.S. $X.X DPI ensifentrine most patients DPI who in market sales that patients the asthma MDI medications, we these millions Similarly, It for COPD convenient are such five the potential and the about ensifentrine billion estimated $X that patients greatly believe for their at million Europe, DPI in valued market devices billion was main and over and COPD. the alone countries for
market So a opportunity. substantial
partner in ensifentrine's inhalers can concept powder formulations ensifentrine. adapted proof dry its used this further realize a commercialization to fully of different enhanced plan and of that be potential. the to of formulation We we believe commercial significantly to will development today and Our market data inhaler value,
for formulation symptomatic pivotal which know, the patients. is you lead the Phase of as Phase in is and next formulation, enter we maintenance our treatment of trials III expect ensifentrine COPD However, IIb to nebulizer year
production with a symptomatic progressive particularly breathlessness is high are inflammatory ensifentrine be sputum cough, need. disease. and medical anti-inflammatory very therapeutic properties alternatives There's from COPD these available of patients. bronchodilator for maybe no helpful chronic cure. a these suffer Few that and patients The for unmet respiratory
route where Our U.S. markets especially and severe function. in patients symptomatic lung remain patients, show nebulized of the for payer million research deteriorating delivery preferred is two the a administration COPD approximately with and more that
treatment development for Despite in remain new for available these patients. patients options taking these medicines, few and treatments severe if any, currently COPD few, there are
In auspice addition, established U.S., for regulatory well products the pathway the development nebulized is on in and particularly FDA. of drug again, under
Phase to an used dose-ranging evaluating COPD. study initiated add-on May as bronchodilator ensifentrine an long-acting treatment or dosing efficacy a establish week nebulized very regimen nebulized program with tiotropium and commonly dose to XXXX, designed ranging moderate-to-severe treat in LAMA of as In trial with safety placebo-controlled, add-on randomized, is Spiriva, in double-blind, patients the III This a COPD Phase four COPD. a to IIb evaluate for potential to the a inhaled and ensifentrine we
IIb in FEVX. improvement of quality as additional in patient Phase measurements COPD lung enroll and by approximately function life primary study XX of is different U.S. XXX will reported outcome include Key by The sites at the with tools. about of patients endpoint study respiratory this measured Peak The endpoints symptoms
to meeting year, Phase U.S. expect end into study progress IIb dosing following to Phase next Phase expected continue year-end week an III II the four around We trials patient complete to FDA. this pivotal in of with
regulatory two information Phase obtained a we ensifentrine, trials, safety pivotal six the duration extension. each of totality the XX-month months III of on and to conduct with of plan them with one Based
patients in I market two on or important Separately, and using conduct triple an in the bronchodilator we to studies the expect We payers plan to regulatory COPD in one to for patients and positioning treatment a expect for only background in trials start, III And to no XXXX. studies therapy. broad patients and additional label. as severe physicians be conduct FEVX we endpoint with Phase COPD dual mentioned, more
of a good anticipate over about ensifentrine. this go be this to development We the value potential. and will we Phase well very year of and half ensifentrine key we update, we believe readouts That to III. have of shown bronchodilator tolerated sustained impact before very effect, ensifentrine's programs DPI has did commercial the the today's commercial potentially talk significantly data and has on Based enhanced on second significant formulation data a
will provide report first to followed FDA, formulation year-end. value year. by dose the from expect ranging start next guidance end for II And Phase this of trial Phase data ongoing study the do MDI We of with study in meeting of IIb around Phase II important our commenced to a days quarter final providing trial from expect an in period, June III multiple for Phase with The clinical first XXX-patient events data that that report believe in dose alternatives single creating we XXXX. dosing the the dose patients the and seven data half year second all with of COPD. We these year, from are this this first treatment anticipate milestones, a additional partner data, of
the CFO, I Piers, will overview. our provide turn to financial call Morgan, Piers a to now please. over
