RedHill Biopharma said Monday that a Phase III study of RHB-104 for people with Crohn's disease met its primary endpoint, as well as key secondary goals. CEO Dror Ben-Asher remarked "we look forward to discussing the path to approval with the FDA and to accelerating discussions with potential pharma partners."
The MAP US trial randomised 331 people with moderately to severely active Crohn's disease to receive RHB-104 or placebo, in addition to baseline background medication. The primary endpoint of the study was the achievement of remission after 26 weeks as measured using a Crohn's Disease Active Index (CDAI) value of less than 150, while key secondary goals included response at week 26, rates of early remission at week 16 and durable response between week 16 and week 52.
Top-line results showed that for the main goal, 37 percent of patients who received RHB-104 achieved remission at week 26, versus 23 percent for placebo. Further results demonstrated that 44 percent of patients treated with RHB-104 also achieved a significantly greater response at week 26, defined as a decrease of at least 100 in CDAI from baseline, compared to 31 percent for placebo.
In addition, the experimental drug was associated with significant benefit versus placebo in achieving early remission, defined as remission at week 16, and durable remission over weeks 16 to 52, defined as continuous remission throughout the period. RedHill added that at 52 weeks of treatment, remission in the RHB-104 arm continued to be favourable to placebo, with rates of 27 percent and 20 percent, respectively, while maintenance of remission at week 52 in subjects who were in remission at week 16 was 25 percent and 12 percent in the two groups.
RedHill noted that RHB-104 was generally safe and well tolerated in the trial, as the rates of serious adverse events and treatment emergent adverse events necessitating treatment discontinuation were similarly low in both study groups. Ira Kalfus, the company's medical director, said "the robust results of this study demonstrate that RHB-104 could become a leading therapeutic option in Crohn's disease."
RHB-104 is an oral combination of antibiotics, with its development based on the hypothesis that Crohn's disease is caused by Mycobacterium avium subspecies paratuberculosis infection in susceptible patients. The drugmaker noted that additional clinical studies are most likely to be required to support a regulatory filing in the US.
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