Quote:

---

But on the issue of whether Ocaliva can actually improve outcomes for NASH patients, the drug once again failed to show a statistically significant benefit at the interim analysis. Only 6.5% of Ocaliva takers enjoyed resolution of NASH with no fibrosis worsening after 18 months, slightly better than 3.5% observed for the placebo group.

Besides, Ocaliva at a lower 10-mg dosing strength didn’t show significant benefits on either endpoint. That’s contrary to the 10-mg dose meeting the statistical significance bar on fibrosis improvement in the original analysis. In its currently FDA-approved primary biliary cholangitis indication, Ocaliva is allowed at 10 mg once daily maximum, and it already carries a black box warning against more frequent dosing .

---