RedHill Biopharma's Crohn's disease drug, RHB-104, successfully met its primary and secondary endpoints, achieving remission at 26 weeks, Reuters reports.
Here's what you should know:
1. RedHill enrolled 331 patients from the U.S., Canada, Europe, Australia, New Zealand and Israel in its phase 3 study. The patients received either RHB-104 or a placebo.
2. The RHB-104 group achieved early remission at week 16 and durable remission between week 16 and week 52.
3. Lead study investigator David Graham, MD, said, "Many patients with Crohn's disease do not achieve remission on current standard-of-care therapies, which are accompanied with poor side effects. RHB-104 appears to have the potential to become a promising, new, orally administered therapy for this important debilitating disease."
4. A phase 3 extension study is ongoing. It's believed several studies will be needed to earn FDA approval.