RedHill Biopharma Ltd. (NASDAQ: RDHL) shares made a solid gain early on Monday after the firm announced positive results from its late-stage trial in Crohn’s disease. Specifically, these were positive top-line safety and efficacy results from the firm’s first Phase 3 study with RHB-104 for Crohn’s disease. The study successfully met its primary endpoint and key secondary endpoints.
Overall, the top-line results in the intent-to-treat population demonstrated superiority of RHB-104 over placebo in achieving remission at week 26, defined as Crohn’s Disease Active Index (CDAI) value of less than 150, the primary endpoint of the study. The proportion of patients meeting the primary endpoint was significantly greater in the RHB-104 group compared to placebo (37% versus 23%).
Patients receiving RHB-104 also experienced a statistically significant benefit in durable remission over weeks 16 to 52, defined as continuous remission throughout the period, (18% versus 9%), demonstrating an improvement of 100% over the placebo.
Ultimately, these results demonstrate that RHB-104 could become a leading therapeutic option in Crohn’s disease worldwide.
Ira Kalfus, M.D., RedHill’s medical director, commented:
This is the first global, double-blind, placebo-controlled study that demonstrates the efficacy of anti-MAP therapy in Crohn’s disease. The availability of antibiotic therapy for treating Crohn’s disease could be transformative. The results from the MAP US study are excellent, successfully meeting the primary endpoint at week 26 and demonstrating that treatment with RHB-104 also has an early benefit at week 16, which is persistent though week 52. The study results compare favorably to existing standard-of-care therapies. RHB-104 appeared to be safe and well tolerated in the study. We continue to analyze the study data and plan to meet with key opinion leaders and the FDA to present the data package and discuss the development path to potential approval of RHB-104.
Shares of RedHill Biopharma were up about 25% at $11.79 in Monday’s premarket, but were up just about 4% to $9.82 after the opening bell. The consensus analyst price target is $21.17, and a 52-week trading range is $4.30 to $11.49.