Antibiotic confers durable clinical remission in Crohn’s
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RHB-104, an oral antibiotic, appeared safe and effective for the treatment of Crohn’s disease, according to the manufacturer.
The phase 3 open label extension study, known as MAP US, includes data from up to 52 weeks of treatment with RHB-104 (RedHill Biopharma), an antibiotic combination therapy that targets Mycobaterium avium subspecies paratuberculosis (MAP), a suspected trigger for CD in susceptible patients. RedHill previously announced positive results out to 26 weeks in the study comprising 331 patients with moderate-to-severe CD who were randomly assigned to receive the drug or placebo.
The company said the study continued to meet its primary endpoint of clinical remission (36.7% vs. 22.4%, P = .0048) as well as secondary endpoints of maintenance of remission at weeks 16 and 52 (25.9% vs. 12.1%, P = .0016) and durable clinical remission on all visits from week 16 through week 52 (18.7% vs. 8.5%, P = .0077).
The open-label extension MAP US2 study evaluated the safety and efficacy of RHB-104 in patients from the MAP US study who had persistent CD (CD Activity index 150) after 26 weeks of the blinded study therapy. The study comprised 54 patients, of which 30 completed 52 weeks of treatment. The study demonstrated clinical remission in 27.8% of patients at week 16 and 22.2% at week 52. Among patients who were initially in the placebo arm of the MAP US study, 31.6% achieved remission at week 16, and 26.3% achieved remission at week 52.
The drug was also generally well-tolerated by patients. Compared with the active arm of the MAP US study, the MAP US2 study had lower incidence of treatment emergent adverse events (87.3% vs. 77.8%), serious adverse events (18.7 vs. 7.4%) and reported adverse events that lead to discontinuation (21.1% vs. 9.3%).
For more information: www.redhillbio.com