Abcuro Presents Results from Phase 2/3 MUSCLE Study of Ulviprubart in Patients with Inclusion Body Myositis at GCOM 2026

• While not reaching statistical significance, there was a slowing of disease progression relative to placebo, as measured by IBMFRS, in the overall patient population at the lower dose of ulviprubart, with a 50% slowing of disease progression relative to placebo across both doses in a pre-specified subgroup of patients with less severe disease
• Ulviprubart demonstrated a favorable safety and tolerability profile compared with placebo in the study
• Study validates ulviprubart’s mechanism of targeted depletion of cytotoxic T cells expressing KLRG1
• Abcuro plans to meet with FDA to discuss next steps to advance ulviprubart in IBM

Excerpt from the Press Release:

NEWTON, Mass.–(BUSINESS WIRE)–Abcuro, Inc., a clinical stage biotechnology company, today presented results at the 6^th Global Conference on Myositis (GCOM) meeting, being held March 23-26, 2026 in Lisbon, Portugal from the Phase 2/3 MUSCLE clinical study of ulviprubart (ABC008), an investigational monoclonal antibody in development for the treatment of patients with inclusion body myositis (IBM). IBM is a rare, debilitating and relentlessly progressive chronic autoimmune disease that currently has no approved treatment options.

“A trend towards slowing of disease progression in patients with less severe disease is encouraging based on the biological hypothesis of how KLRG1+ T cells destroy muscle fibers over time. This pattern is consistent with observations in other diseases, where therapeutic effects are more readily detected in earlier stages,” said Namita Goyal, MD, Director of the Neuromuscular Center at the University of California, Irvine School of Medicine, and principal investigator of the MUSCLE study. “It also underscores ulviprubart’s unique mechanism targeting highly differentiated cytotoxic T cells expressing KLRG1. IBM is a devastating, progressive disease with no approved treatment options that affects tens of thousands of patients around the world. The significant unmet need in IBM cannot be overstated, and patients, care partners, and healthcare providers are united in seeking a safe and effective treatment.”

Key Highlights from Oral Presentation:

MUSCLE (NCT05721573) was a global Phase 2/3 clinical trial evaluating ulviprubart, dosed once every eight weeks (Q8W), in patients with IBM. The primary endpoint was change from baseline in IBM Functional Rating Scale (IBMFRS) total score at Week 76 compared to placebo.

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