Abcuro, a company specializing in musculoskeletal disorders, has recently completed enrollment for its MUSCLE registration phase 2/3 clinical trial. This trial is focused on evaluating the effectiveness of ulviprubart (ABC008) in treating inclusion body myositis (IBM), a rare and debilitating condition with no current treatment options.
The trial is a global, randomized, double-blind, placebo-controlled study that will assess two different doses of the drug (0.5 mg/kg and 2 mg/kg) compared to a placebo over a period of 76 weeks, followed by a 4-week safety observation period. The primary goal of the trial is to determine the efficacy, safety, and tolerability of ulviprubart in patients with IBM.
Dr. H Jeffery Wilkins, Chief Medical Officer of Abcuro, expressed optimism about the potential of ulviprubart to address the significant unmet need in treating IBM. The drug targets KLRG1 and is considered a first-in-class therapy for this condition. Initial data from the phase 2/3 MUSCLE trial is expected to be released in the first half of 2026.
Paula J. Eichenbrenner, CEO of The Myositis Association, highlighted the challenges faced by individuals and families dealing with IBM. The disease can cause a drastic reduction in quality of life and make everyday activities difficult. Without disease-modifying treatment options, IBM patients and their families are left managing the progressive muscle loss and the impact it has on their lives.
Overall, the completion of enrollment for the MUSCLE trial represents a significant milestone in the development of a potential treatment for IBM. Abcuro’s dedication to addressing the needs of patients with this rare condition is a positive step forward in the field of musculoskeletal disorders.
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https://pharmafile.com/news/abcuro-completes-enrolment-for-phase-2-3-ibm-treatment-trial/