Abcuro, Inc., a clinical-stage biotechnology company developing therapies for the treatment of autoimmune diseases and cancer through precise modulation of cytotoxic T cells, today announced the completion of enrollment of the registrational Phase 2/3 MUSCLE clinical trial evaluating ulviprubart (ABC008) for the treatment of inclusion body myositis (IBM).
“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 program,” said H. Jeffery Wilkins, M.D., Chief Medical Officer of Abcuro. “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.”
"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,” said Paula J. Eichenbrenner, MBA, CAE, Executive Director of The Myositis Association. "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."
The Phase 2/3 MUSCLE clinical trial (NCT05721573) is a global, randomized, double-blind, placebo-controlled, parallel multicenter registrational trial evaluating ulviprubart in patients with IBM. The objectives of the trial are to evaluate efficacy, safety, and tolerability of two dose levels of ulviprubart (0.5 mg/kg and 2.0 mg/kg) compared with placebo at 76 weeks in subjects with IBM followed by a 4-week safety follow-up period.
About Ulviprubart
Ulviprubart (ABC008) is a first-in-class anti-KLRG1 antibody product candidate capable of selectively depleting highly cytotoxic T cells, while sparing naïve, regulatory and central memory T cells. Ulviprubart is designed to treat diseases mediated by highly cytotoxic T cells, including the autoimmune muscle disease inclusion body myositis (IBM), T cell large granular lymphocytic leukemia (T-LGLL), and mature T cell malignancies. The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have each granted orphan drug designation to ulviprubart for the treatment of IBM.
About Inclusion Body Myositis (IBM)
IBM is an autoimmune disease in which highly cytotoxic T cells chronically attack muscle tissue leading to progressive weakness and limb muscle atrophy. Patients progressively lose muscle function, including loss of grip, dexterity and mobility. There are currently no available disease-modifying treatment options for IBM. Based on published epidemiology literature, it is estimated that there are more than 50,000 people with IBM across the US and Europe.
About Abcuro
Abcuro is a clinical stage biotechnology company developing first-in-class immunotherapies for the treatment of autoimmune diseases and cancer through precise modulation of highly cytotoxic T cells. The company’s lead program is ulviprubart (ABC008) and is currently in clinical trials for inclusion body myositis (IBM) and T cell large granular lymphocytic leukemia.
For more information, visit us on LinkedIn and at abcuro.com.
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Contacts
Matthew DeYoung
Investor Relations and Media
Argot Partners
abcuro@argotpartners.com
