Intercept's (ICPT) OCA Ph3 Trial Design or Size Not Seen as Surprise - Deutsche Bank
Shares of Intercept Pharmaceuticals (NASDAQ: ICPT) declined pre-market after it announced its plans for an international Phase 3 trial of OCA. Deutsche Bank's Alethia Young is not surprised by the design or size of this trial.
Young added that the File-able surrogate endpoint at 72 weeks was in-line with expectations. Young also said endpoints of the trial are not surprising and are in-line with management commentary.
"Primary endpoint is a co-primary endpoint of 1) fibrosis improvement- proportion of patients getting at least one stage of fibrosis improvement w/ no worsening of NASH and 2) NASH resolution with no worsening of fibrosis- proportion of patients. In Flint their Ph2b, OCA saw a stat sig fibrosis benefit of 35% vs. placebo of 19% with a p value of .004 (this was a secondary and the trial was not powered). Mgmt has talked about upping the efficacy bar in Phase 3 to include fibrosis improvement as a primary endpoint. We think NASH clearance is an important efficacy measure. In FLINT, NASH resolution was a secondary endpoint and 22% in OCA achieved endpoint vs. 13% in the placebo which was not significant with a p-value of .08. As we mentioned before, we thought in a bigger study (2500 pts in Ph3) vs. Flint (~283 patients) that they should have better powering on this endpoint," said Young.
"1400 patients at interim will be needed for accelerated approval. The final clinical outcomes are powered at 2500. Two doses vs. one dose is being studied with 1:1:1 randomization. It is enrolling at 250 sites globally. There is an important balance to be struck between fast enrollment and screening of the right patients. We have seen competitor trials enroll fast but there is risk to too fast enrollment as well. Assumptions around powering were not included in this release. We do think that it is important to study 2 doses of OCA to better understand the pruritis and lipids profile at lower doses. We had thought 2 trials with 1000+ people previously vs. one trial but the numbers were relatively similar. Trial size is in-line with mgmt expectations. Co has not given guidance on NASH approval. The accelerated approval endpoint requires 1400," added the analyst.
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Shares of Intercept Pharmaceuticals closed at $313.98 yesterday.