RedHill Biopharma announced positive safety and efficacy data for RHB-104 in the Phase 3 MAP US study in Crohn’s disease. The randomized, double-blind, placebo-controlled MAP US study (N=331) achieved its primary endpoint and key secondary endpoints in the intent-to-treat (ITT) population.
RHB-104 is an investigational, proprietary oral antibiotic combination that contains potent intracellular, antimycobacterial, and anti-inflammatory properties. The novel treatment is based on the hypothesis that Crohn’s disease is caused by Mycobacterium avium subspecies paratuberculosis (MAP) infection in susceptible patients.
In the trial. participants were randomized to RHB-104 or placebo in addition to background medication, including 5-ASAs, corticosteroids, immunomodulators, or anti-TNFα agents. For the primary endpoint of achieving remission at week 26 (defined as Crohn’s Disease Activity Index [CDAI] value <150), treatment with RHB-104 was statistically significantly superior to placebo (37% vs 23%; P=.013).
For the major secondary endpoints, patients had a statistically significantly greater response at week 26 (defined as decrease of ≥100 CDAI from baseline) in the RHB-104 group vs placebo (44% vs 31%; P=.028). Additionally, patients treated with RHB-104 had a statistically significant benefit in achieving early remission at week 16 (42% vs 29%; P =.019). Continuous durable remission was seen over weeks 16 to 52 in the RHB-104 group vs placebo (18% vs 9%; P =.038), representing a 100% improvement over placebo.
At week 52, remission in the RHB-104 arm was superior to placebo (27% vs 20%; P =.155), and patients still in remission at week 52 who entered remission at week 16, experienced a statistically significant benefit with RHB-104 vs placebo (25% vs 12%; P =.007).
With regard to safety, RHB-104 was generally safe and well tolerated. There were similar rates of serious adverse events and treatment-emergent adverse events leading to study discontinuation among the 2 study arms. Future data on other exploratory endpoints (mucosal healing, MAP status, quality of life, sub-population analyses, pharmacokinetics) will be assessed as the data become available.
“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,” stated Ira Kalfus, MD, Medical Director at RedHill.
For more information visit RedHillBio.com.