RedHill Biopharma Ltd. enrolled the final patient for its Phase IIa, proof-of-concept study testing RHB-104 in patients with relapsing remitting multiple sclerosis (RRMS) who test positive for Mycobacterium avium subsp. paratuberculosis (MAP). RedHill is evaluating RHB-104 as an add-on therapy to interferon beta-1a for a treatment period of 24 weeks.
“We are very pleased to have completed patient enrollment in the Phase IIa CEASE-MS study with RHB-104,” stated Clara Fehrmann, Director of Clinical Operations at RedHill, in a news release from the company. “The CEASE-MS study was initiated following four successful pre-clinical studies and is based on the hypothesis that a bacterially induced dysregulated immune system plays a role in the pathogenesis of multiple sclerosis.”
RHB-104 is a novel oral capsule formulation of an antibiotic combination therapy that has potent intracellular, anti-mycobacterial, and anti-inflammatory properties. The capsules consist of 95 mg of clarithromycin, 45 mg of rifabutin, and 10 mg of clofazimine. Although RHB-104 was originally pursued as a treatment for Crohn’s disease (it is now in Phase 3 clinical trials for Crohn’s), the hypothesis for using it to help treat RRMS is that the anti-inflammatory and neuroprotective properties of this drug combination will dampen the effects of RRMS.
This hypothesis has been tested in several preclinical studies and is now being tested in the clinical trial, “Proof of Concept Study of RHB-104 as Add-On Therapy to Interferon Beta-1a in Relapsing Remitting Multiple Sclerosis (RRMS) (CEASE-MS).” Now that all patients have been enrolled, the study is no longer recruiting, and the last patient will finish treatment 24 weeks after beginning treatment with RHB-104. A total of 18 patients are enrolled, and each will be treated with RHB-104 under an open label fashion.
“We are hopeful that the interim results from the CEASE-MS study, expected in late 2015 or early 2016, will contribute to the understanding of the development of multiple sclerosis and will provide new treatment alternatives for patients suffering from this disease,” stated Fehrmann. Outcomes include combined unique active lesions, MAP status, and relapse rate after 24 weeks of treatment. Positive outcomes will likely lead to more clinical studies to further demonstrate safety and efficacy of RHB-104 in RRMS.