Immunotherapy developer Abcuro is pressing forward with its clinical program for inclusion body myositis (IBM) despite missing the mark in a recent late-stage trial. The company has secured $66 million in Series D funding to initiate a new study in patients with less severe forms of the disease, where earlier analyses suggested greater therapeutic potential.
Based in Newton, Massachusetts, Abcuro is developing ulviprubart, a monoclonal antibody designed to selectively target and deplete pathogenic T cells expressing killer cell lectin-like receptor G1 (KLRG1), while sparing other components of the immune system. IBM is a progressive muscle-wasting condition characterized by immune cell infiltration into muscle tissue, leading to gradual deterioration of muscle function over time.
The Phase 2/3 trial results, presented in March at the Global Conference on Myositis, did not achieve statistical significance in the overall patient population. However, Abcuro highlighted encouraging trends, including a measurable slowing of disease progression compared to placebo. In a pre-specified subgroup analysis focusing on patients with milder disease, the study demonstrated a 50% reduction in disease progression rate. The therapy also maintained a strong safety and tolerability profile throughout the trial.
Approximately 40,000 individuals in the U.S. have been diagnosed with IBM, with Abcuro estimating that roughly half fall into the less severely affected category. The newly acquired capital will finance a pivotal-level trial planned for launch in the fourth quarter of this year, contingent upon alignment with FDA feedback. The company noted ongoing regulatory engagement aimed at defining a viable path toward approval.
The funding round was led by New Leaf Venture Partners, with participation from existing and new investors including NEA, Bain Capital Life Sciences, Samsara BioCapital, Redmile Group, Mass General Brigham Ventures, RA Capital Management, Pontifax, Sanofi Ventures, Foresite Capital, Eurofarma Ventures, Kaitai Capital, Soleus Capital, abrdn Inc., along with individual investors Nancy Chang and Shang Bay, and Rock Springs Capital.
This follows a $200 million Series C financing in early 2025 led by New Enterprise Associates.
Photo: RomoloTavani, Getty Images
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