Abcuro completes enrolment for phase 2/3 IBM treatment trial
Betsy Goodfellow | June 26, 2024 | News story | Research and Development | Abcuro, Musculo-skeletal disorder, ibm, inclusion body myositis, ulviprubart
Abcuro has announced that it has completed the enrolment for its registrational phase 2/3 MUSCLE clinical trial, which aims to assess ulviprubart (ABC008) for the treatment of inclusion body myositis (IBM).
The trial is a global, randomised, double-blind, placebo-controlled, parallel multicentre registrational trial assessing the drug in patients with IBM, aiming to evaluate the efficacy, safety and tolerability of two dose levels of the drug (0.5mg/kg and 2mg/kg) compared to placebo over a 76-week period, followed by a 4-week safety follow-up period.
H Jeffery Wilkins MD, chief medical officer at Abcuro, commented: “We continue to focus on advancing our product candidate ulviprubart to treat patients with IBM who currently have no treatment options and are therefore delighted to achieve another important milestone for this clinical programme. Ulviprubart is a first-in-class therapy targeting KLRG1 and has great potential to transform the treatment paradigm for IBM where there is currently a significant unmet need. We look forward to sharing initial data from the phase 2/3 MUSCLE trial in the first half of 2026.”
Paula J Eichenbrenner MBA CAE, executive director of The Myositis Association, added: “IBM is a tremendously debilitating disease which drastically and irreversibly reduces quality of life. Families are deeply affected as they witness their loved one’s decline, while troubleshooting each facet of daily life to accommodate the condition. Living with IBM can make basic daily activities difficult and can negatively impact larger goals like maintaining hobbies and travel. IBM patients have no recourse in the current therapeutic landscape. Exercise and physical therapy can preserve muscle and stave off disease progression, but only to a degree. The lack of disease-modifying treatment options places more burden on IBM families as they must help their loved ones to manage anxiety about the inevitable muscle loss they will endure and feelings of being trapped with this rare, catastrophic disease.”
Betsy Goodfellow
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