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DSMB supports trial of oral antibiotic for Crohn’s disease

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The independent Data and Safety Monitoring Board has unanimously recommended the continuation of the phase 3 MAP US study evaluating RHB-104, an investigative oral antibiotic therapy for Crohn’s disease, according to RedHill Biopharma, who remains blinded to the data.

RHB-104 is a “potentially groundbreaking” oral antibiotic combination therapy with intracellular, antimycobacterial and anti-inflammatory properties that targets Mycobacterium avium subspecies paratuberculosis (MAP), a bacterial infection and a suspected cause of Crohn’s disease, according to a press release.

In this double-blind trial, investigators have randomly assigned 300 of a planned 410 participants at up to 150 international clinical sites to receive the study drug or placebo, with remission at week 26 serving as the primary endpoint.

The first pre-planned meeting with the DSMB took place in December 2016, during which the board also unanimously recommended continuation of the study as planned. For this second pre-planned meeting, the DSMB reviewed safety and efficacy data on the first 222 patients who completed week 26 assessments in the trial, and again unanimously recommended continuation. A third safety-focused meeting is planned for when 75% of participants have completed 26 weeks of the study. The company expects the study data to support a new drug application for RHB-104.

A phase 3 open-label extension study called the MAP US2 study is also ongoing in patients who remain out of remission after the 26-week study period.

“We are very encouraged by [the DSMB’s] 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,” Ira Kalfus, MD, medical director at RedHill, said in the press release. “We continue to enroll subjects and expect to complete enrollment in the study in the first half of 2018.”

Disclosures: Kalfus is employed by RedHill.