Phase 2 Study of Oral Antibiotic to Treat Relapsing MS, RHB-104, Nearing Finish
RedHill Biopharma announced that the final patient has completed the last step of its Phase 2 clinical study (CEASE-MS) of RHB-104 as a potential treatment for people with relapsing-remitting multiple sclerosis (RRMS). RHB-104 is an antibiotic oral medication that blocks inflammation in addition to killing bacteria.
RHB-104 was originally developed as a treatment for Crohn’s disease, and is currently in Phase 3 study to analyze its effectiveness in treating this inflammatory bowel disease.
“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,” Clara Fehrmann, RedHill’s director of Clinical Operations, said in a company press release.
The Phase 2a proof-of-concept study (NCT01717664) focused on evaluating the safety and effectiveness of RHB-104, combined with interferon beta-1a, for RRMS. Eighteen individuals with RRMS received treatment with RHB-104 and interferon beta-1a for 24 weeks, and were evaluated for an additional 24-week follow-up period during which they took only interferon beta-1a. The company expects final study results in late 2016. Disease-related outcomes include damage due to MS-related loss of myelin (lesions), and whether new symptoms appear (relapse rate).
Prior results from an initial 24-week analysis showed that the drug is safe and effective, and that it should be studied further. Based on two different types of analysis (modified intent-to-treat and per-protocol) 88% or 100% of those taking the medication were free from relapse after 24 weeks. Expanded Disability Status Scale (EDSS) scores, an established measure of MS-related disability, did not increase in any of the study’s participants. Overall, EDSS remained stable and even showed some signs of improvement. The researchers measured an active lesion in only one study subject.
Further positive results will likely lead to the therapy’s advancement in clinical studies, possibly to Phase 3, the final step needed before a drug can be reviewed for approval by the U.S. Food and Drug Administration (FDA).
Multiple sclerosis (MS) is a disease in which myelin, which helps nerve cells to conduct impulses, is destroyed by an overactive immune system, a condition known as inflammation.
RedHill Biopharma is based in Israel and focuses on inflammatory diseases, such MS and gastrointestinal problems.