RedHill Biopharma has completed the last dosing and scheduled follow-up patient visit ahead of top-line interim analysis in the Phase IIa proof-of-concept clinical study evaluating RHB-104 in patients treated for relapsing-remitting multiple sclerosis (RRMS).
RHB-104 is a proprietary and potentially groundbreaking antibiotic combination therapy in oral capsule formulation, with potent intracellular, anti-mycobacterial and anti-inflammatory properties.
The open label Phase IIa study (the CEASE-MS study) is being conducted in two medical centers in Israel. Eighteen patients suffering from RRMS were enrolled in the study, which was designed to assess the efficacy and safety of RHB-104 as an add-on therapy to interferon beta-1a.
Patients received 24 weeks of treatment with RHB-104 and are being evaluated for an additional period of 24 weeks after completing treatment.
The primary endpoint of the Phase IIa CEASE-MS study is the number of combined unique active lesions after 24 weeks of treatment with RHB-104, as compared to baseline. Additional endpoints include changes in cytokines, relapse rate, Expanded Disability Status Scale (EDSS) and the safety and tolerability of RHB-104.
Top-line interim results are expected to be announced early in the first quarter of 2016. A full analysis and the final Clinical Study Report (CSR) are expected during the second quarter of 2016.
RedHill director of clinical operations Clara Fehrmann said: “The completion of the final dosing in the active treatment phase of the Phase IIa CEASE-MS study is an important milestone in RedHill’s RHB-104 development program. Top-line interim results will become available in the coming months and we are hopeful that they will support the hypothesis that RHB-104 may counterbalance a dysregulated immune system which plays a critical role in the pathogenesis of multiple sclerosis.”
Multiple sclerosis is an inflammatory, demyelinating and neurodegenerative disease of the central nervous system of uncertain etiology. It exhibits characteristics of both infectious and autoimmune pathology. It is estimated that the worldwide market for multiple sclerosis therapies will exceed $17 billion in 20151.
RHB-104 is a multifaceted drug that, in addition to bactericidal properties against intracellular infections, has potentially distinct mechanisms of action that include both anti-inflammation and neuroprotection. The Phase IIa CEASE-MS study was initiated following several successful pre-clinical studies conducted by RedHill with RHB-104.
The pre-clinical studies demonstrated that RHB-104 inhibited production of pro-inflammatory cytokines IL-6 and TNF, indicating that RHB-104 could be a potential therapy for inflammatory diseases where these cytokines have been shown to play a critical pathological role.
RHB-104 is also being evaluated as a treatment for Crohn’s disease and is currently undergoing a first Phase III clinical study in the U.S. and other countries (the MAP US study). Interim analysis of the MAP US study is expected in the second half of 2016. The primary endpoint is remission at week 26 of treatment.
A second Phase III study with RHB-104 for Crohn’s disease is being planned in Europe (the MAP EU study), with Clinical Trial Applications (CTA) already accepted by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) and additional European agencies.
Published 01 December 2015