- RedHill Biopharma (NASDAQ:RDHL) says the market may be "confused" with the week 52 remission secondary endpoint from its Phase 3 clinical trial evaluating RHB-104 in Crohn's disease patients. Shares, initially up, sold off in apparent reaction to the endpoint which appeared to show only a modest separation from placebo.
- The company says the endpoint measured "late induction of remission" and did not evaluate the preservation of remission over time. In other words, the endpoint meant to capture those patients who may have needed more than 26 weeks of therapy for initial induction of remission.
- As far as maintenance of remission is concerned, the study showed that, from the induction of remission at week 16 to week 52, RHB-104 was twice as effective as placebo (25% vs. 12%; p=0.007), performance on par with other standard-of-care treatments.
- Shares are down a fraction premarket.
- Previously: Redhill surrenders bulk of gain on weak 52-week remission data on RHB-104 (July 30)
- Now read: RedHill Biopharma (RDHL) MAP US Phase III Positive Top-Line Results RHB-104 for Crohn's Disease - Slideshow
Original article