day agonist you enrollment PBC; early earlier X initiation, X cholangitis, expected, several updates or PPAR-delta line with cholangitis, afternoon, for year global announced primary of today selective in the or of today PSC; inflammatory liver top primary begin to we Yesterday, with us. steatohepatitis, biliary randomization since development XXX by patients, expect our or in and with including call diseases, in almost complete and multiple reached data XXXX. related seladelpar, Phase We to ENHANCE, exciting potent PBC. highly currently this that patients and nonalcoholic for in joining now target and I our seladelpar to than our thank Good sclerosing we registration to the Phase its had month end X study of report NASH.
milligrams safety randomized, with response placebo-controlled, inadequate efficacy UDCA. intolerant As a of and reminder, have who the X first-line to in are or evaluating XX-week with and versus is a placebo an double-blind, study had ENHANCE patients XX of PBC treatment seladelpar
to the inflammation ENHANCE our the being efficacy in study. symptoms cholestasis, PBC not from of by the age fibrosis, is result destruction the women familiar, and include a potentially of the which the X can Importantly, bile liver the the leading fatigue and of toxic primary of in bile evaluated disease treatment identical doses and those debilitating characterized case chronic endpoints In disease Phase XX. is clinical It acids Common ducts, or and primarily and of to over liver, inflammatory bile being failure. liver duration affecting impaired pruritus. intrahepatic seladelpar flow, cirrhosis studied, accumulation are in are rare you
to well for based date study Enrolling of together achievement there unmet need in the and team its a of a significant on minds reputation that our still working therapy seladelpar ahead already patients, of a as staff approved an X. rare of to statement this is is as in profile with the investigators, exists schedule. our the our testament a in in overemphasize Phase their to disease size this study enrolled cannot which get I patients, partners, about
our of expect early next line full to release year. we data study, top Phase dose-ranging open-label Speaking X ongoing
These As presentations at over this X recently consecutive may results seladelpar tolerability past and meetings treatment. sets PBC the to supported patients April. you access recall, in seladelpar the and past therapy X various our late-breaking existing most presented have in breakthrough interim prime years served and AASLD improved study from designations at and second-line data efficacy this establish EASL been offer of potential better for to over
demonstrated a effects. has To anti-inflammatory date, and anticholestatic pattern seladelpar of
total long-term with patients PBC. electing study. observed a X year advantage without these key of our current seladelpar to worsening a study in XXX for pruritus, effects we potential This out with patients, continue treatment XXX of a Importantly, treatment patients of randomized over eligible second-line XXX beyond
safety over two years. experience the with patients study and now patients continues there XX grow, seladelpar for been PBC to over long-term have Our in are with on who in treatment
for by PBC hosted Meeting November our the as and Boston seladelpar Finally, data key we'll Liver program be achieve AASLD XX. clinical upcoming continues preclinical milestones, presenting X from through at new to in
The first presentation or of compensated patients PBC cirrhosis. without in with pharmacokinetics the examines seladelpar
in of confirmed is Saturday, X:XX p.m. Eastern X:XX from similar regulators. EASL in signals this on treatment of we number any without and observed It this seladelpar challenging and exposure last to anticholestatic clinicians overt of It anti-inflammatory the time. compensated and XXXX our abstract PBC builds at patients cirrhosis, X, both upon April will safety in cirrhotic you those November increasing For presentation attending, an population. effects in noncirrhotic focuses new and with which patients or on be area for presented interest
understand PBC seladelpar severity, results reflects it of As share these communication is of and spectrum disease our broadly to our to commitment we what effects learn. the of advances, program across the believe PBC we vital
how XXXX, the structural to and in presented will selectivity elafibranor, Eastern be gives at selectivity the target the Monday, level dual the and the highlight and of of November second the abstract, of clinical number doses structural differences level time. XX:XX at characterization from in of The p.m. XX, agents. It and of origins a biophysical seladelpar differences why explores is on potential X:XX these its and achieve agonist. to This seladelpar insights PPAR-alpha-delta and origins of able poster potency will
last affects is quarter, we our In of objective a significant diseases. seladelpar discussed cholestatic fibrosis more the patients inflammation third this the in PSC. The liver PSC underlying liver that U.S. development XX,XXX heterogeneous bile of chronic rare in it PBC, a diffuse and seladelpar we disease. approximately ducts. pathology of shares of rare progress generally is expanding a characterized the cholestatic is on by initiation and disease although orphan disease some the we X patients study with with made are to quarter, committed As with proof-of-concept Phase for
There many is from option for a disease high transplant. comorbidity need also with of patients in no pruritus, is approved As PBC, suffer liver patients bowel with this and population. inflammatory only in significant unmet is PSC pharmacologic there treatment. effective a The
each seladelpar for include efficacy from in the to to evaluating include investigator secondary at group change a -- inflammation proof-of-concept XX We milligrams placebo relative X of MRI versus also placebo fibrosis. interim we will Key and stiffness XX including an of life, seladelpar are site a completed initiations endpoint and safety activity. endpoints potential XXX to enrollment evaluations and and biomarkers doses The group X and -- In by endpoint in dose of now weeks weeks The study in sites serum ratio, will after as meetings Phase are liver patients and patient patients of FibroScan, X recently with X, XX of MRCP, U.S. pharmacologic baseline will in and study, other of and to dose including primary screenings patient quality X XX and reach alkaline efficacy contrast to measurements globally. exploratory be approximately XX targeting measures, assessment will way. phosphatase X the X treatment. XX of imaging be Europe, this under approximately and pruritus
We guidance further final with as the provide months timelines line data we top interim enrollment. will coming progress for and on anticipated in
liver can patients NASH. This in only is disease our in areas medical PBC our development for not seladelpar of for of you evaluation true unmet need. program seladelpar is also but focused PSC, see, As of high in and with inflammatory our in diseases cholestatic
ongoing with ask Xb me to updates Let Chuck? study NASH. Phase in our provide Chuck
