It’s the second time a board has reviewed the MAP US study. The first time, in December 2016, it also made a unanimous recommendation that the study continue.
This time the board had to decide if the RHB-104 combo was achieving a certain level of effectiveness, compared with a placebo. It agreed that the therapy was.
The MAP US study (NCT01951326) is evaluating the safety and effectiveness of a combination of RHB-104 and other therapies in patients with moderate to severe Crohn’s disease. The study’s primary objective is for patients to achieve remission — that is, eliminate signs of the disease — within 26 weeks.
Besides RHB-104, the combination includes clarithromycin, rifabutin and clofazimine.
So far, 222 people have completed the 26-week assessment. Overall, 300 of what RedHill hopes to be 410 subjects have been randomized to receive either RHB-104 or a placebo.
Researchers are still recruiting participants in up to 150 trial sites in the United States, Canada, Israel, Australia, New Zealand and some European countries.
RHB-104 has anti-bacterial and anti-inflammatory properties. RedHill developed it after studies showed that Crohn’s may stem from Mycobacterium avium subspecies paratuberculosis, or MAP, infections.
That research has indicated that MAP infections may disrupt normal immune functioning, triggering the development of autoimmune diseases.
“RHB-104 is a potentially ground-breaking new therapy for Crohn’s disease,” Dr. Ira Kalfus, RedHill’s medical director, said in a press release. The review board has looked at the “interim safety and activity results of the Phase 3 MAP US study, and we are very encouraged by its unanimous recommendation to continue the study through randomization of all planned 410 subjects, with no changes to the protocol, investigator’s brochure, study conduct or informed consent form.”
The U.S. Food and Drug Administration has given a qualified infectious disease product designation to RHB-104 as a treatment for nontuberculous mycobacteria infections. This is a step toward the therapy receiving accelerated regulatory review.
A Phase 3 extension trial — MAP US2 (NCT03009396) — is under way in parallel with the MAP US study in patients who were unable to achieve remission in 26 weeks.
A third review board meeting is expected when 75 percent of the expected 410 participants have completed 26 weeks of the trial.
“We continue to enroll subjects and expect to complete enrollment in the study in the first half of 2018,” Kalfus said. “I would like to thank the DSMB [review board] members for their professional and independent assessment of the study data and for their positive recommendation.”
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