Researchers found that adding an antibiotic to the therapy plan reduces relapse rates and brain lesion in multiple sclerosis.
This is interesting since multiple sclerosis is known to be an autoimmune disease. Meaning, the immune system of the human body attacks cells of the own body. Antibiotics are usually used in infectious diseases (a bacterium is attacking the cells of the body).
This would support previous studies suggesting that Mycobacterium avium subspecies paratuberculosis (MAP) is linked to the development of MS.
It was a small Phase 2a clinical trial including 18 participants (10 finished) with relapsing-remitting multiple sclerosis (RRMS). The participants were treated with interferon beta-1a for an average of five years before entering the study
• RHB-104 for 24 weeks, as an add-on to interferon beta-1a therapy.
• Patients were monitored for an additional 24 weeks, during which they returned to interferon beta-1a treatment alone.
• ARR (annualized relapse rate) with antibiotic: 0.29 during the first 24 weeks
• ARR without antibiotics (previous trials): 0.31 to 0.67 for Avonex, 0.39 to 0.91 for Rebif
• Relapse free with antibiotics: 88% (first 24 weeks), 93% (following 24 weeks)
• Relapse free without antibiotics (previous studies): 63% (Avonex), 75% (Rebif)
Ira Kalfus, MD, Medical Director of RedHill and the CEASE-MS study said, “We are very pleased with the final results from the CEASE-MS Phase IIa proof-of-concept study with RHB-104 for relapsing-remitting multiple sclerosis (RRMS). The findings from the study, including safety, clinical and MRI, support the therapeutic potential of RHB-104 as an add-on therapy in RRMS.
However, the study group was very small and future research will be needed to support the findings.
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