Yas, off appreciate I'll to the ask you, of some the Thank questions. points. on start elaborate and team perhaps these
first enhanced of at I We're in population, the repeat respect and and secondary study. with the and endpoints. in same looking a the same key optimal really XX-milligram patient Phase RESPONSE. I'd dose fully ENHANCE and executed of and to III largely, this seladelpar same same how the prior X the talked past We've think to we say rinse of all, like at enrolled length is what about primary
some Phase on fashion, II we really baseline all of our the in guys, see we've anything course, blinded study XXX seen mean, wouldn't in high-level to in expect prior I enrolled as we different we the over Of demographics. you patients that enrolled open-label that patients ENHANCE. a well ability as see the have XXX to tell what from simply I
terms with we've -- powering. know what very likely second with has particular before. to alkaline see I would I seen very would you in consistent So And demographics of again, a think at phosphatase the question do baseline. levels in be reminder RESPONSE around your overall comparable
seladelpar months endpoint to register A I at particular in is the this the you of we endpoint phosphatase and would medical think the of to XX data, X.XXx for data normal in that bilirubin. has below X a that their about at versus composite in order patients be per ENHANCE X and upper XX% level alkaline be included even treatment, a response look recall, milligrams of we've rate registration And in at just XX% patient resulted Ocaliva, in normal, when saw responder. arm. within that the particularly, meetings, previously that about on in shared phosphatase for used as months least primary presented XX.X% drop on that primary drop patients the which to that just we data about endpoint a those XX placebo, seladelpar, limit the endpoint may you alkaline with
than endpoint, X.XXXX. on the So less was primary that p-value
it's a you patients in RESPONSE way long-winded placebo. seladelpar primary on me milligrams that with the so randomized endpoint for tell to X:X, And XX XXX to
We highly respect normalization on XX% type over the an end point are phosphatase demonstrate cases. of to those of each overpowered so in that alkaline effect key well to with secondary
for We we RESPONSE XXX moderate of Our in enroll would target in the relative patients initially built Phase patients largely to study. to able was would to around itch. some many how assumptions the RESPONSE severe be believe, III
benefit total on in on powering terms period. that And for XX% what of benefit the in itch is a X-point rating largely of Again, seladelpar so the key the target in worst XX-hour the XXX end XX% to point target imaginal impact RESPONSE. least the largely fills an assumption patients or at around prior XX% scale show numerical secondary -- drove
surrogate endpoint the study. fact, in and do outcome various is years dialogue based little a of study, We've I us with outcome the designs. this of IV primary H Yasmeen, in Phase commit had, dialogue bit agency asked as surrogate with to expect the course, about on think Phase a to endpoint so around to approval, on approval have RESPONSE agency types a you've as we our Finally, study IV of Subpart with
what the importance in data approach completion agency share treatment dialogue will have challenges we'll That PBC others with least patients eventually IV of if the dialogue bit to dialogue Yasmeen, treatment, what others evaluate we seen ultimately the alone the centered initiation generate in really potential of the little complete our continues that has of a registry patients approval. that point having to recognize are a order our events continuing enough alternatives demonstrate as those around for with be program time publicly, not say, at enough field, can this long-term study. of into talked is set to set, You outcome full real-world with seen our clinical about also recruiting that development novel in Phase more very that the effects data, we've that and to as placebo-controlled we which benefit Phase sponsors. And in than agency, we've other we, today. approaches at see around III that with data versus the hard generate I on for and and sponsors data trials
important and like it's different strategies sponsors a to resources results, that's to really these devote to key can of incumbent multiple CymaBay generating point to on behalf commitment and that potentially data upon as outcome think patients sets I regulators. time