RedHill Biopharma has announced “encouraging” top-line interim results from its CEASE-MS Phase IIa proof-of-concept (PoC) clinical study evaluating fixed oral doses of RHB-104 in patients treated for relapsing-remitting multiple sclerosis (RRMS).
Ira Kalfus MD, Medical Director of RedHill and the CEASE-MS study said: “We are very pleased with the interim results. The initial findings from the study, including safety, clinical and MRI, support the therapeutic potential of RHB-104 as add-on therapy in RRMS.
“Although designed as an exploratory proof-of-concept study in a very small patient population and not powered for efficacy, the study interim results demonstrate positive safety data and clinical signals, supporting additional studies to better investigate the therapeutic potential of RHB-104 in RRMS. A positive efficacy signal was seen in reduction of total T2 lesion volume at 24 weeks compared to baseline. Moreover, EDSS scores were stable with suggestion of improvement. Notably, no patients experienced an increase in total EDSS, further underscoring the therapeutic potential of RHB-104 for the treatment of RRMS.”
RHB-104 is an orally administered antibiotic combination therapy. The ongoing CEASE-MS Phase IIa clinical study is a single-arm, open-label PoC study evaluating fixed oral dose RHB-104 as add-on therapy to interferon beta-1a for the treatment of RRMS.
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