Abcuro secures US $200M to bring IBM drug to market

USA – US biotech company Abcuro has raised US $200 million in its latest funding round, which will help support the final-stage trial of its lead drug, ulviprubart, and prepare for regulatory approval.

If successful, this treatment could become the first FDA-approved drug for inclusion body myositis (IBM), a rare and debilitating muscle disease.

Understanding IBM and the need for treatment

IBM is a progressive autoimmune disease that causes muscle inflammation and weakness, similar to muscular dystrophy. It primarily affects people over 50, with men being more commonly diagnosed than women.

The Muscular Dystrophy Association estimates that around 20,000 people in the US live with IBM. Unlike other autoimmune diseases, IBM does not typically respond to steroids or immunosuppressants, leaving patients with limited treatment options.

Current management includes physical therapy, occupational therapy, and exercise to slow progression.

Currently, no FDA-approved treatments exist for IBM. Common autoimmune therapies, such as corticosteroids and immunosuppressants, have shown little to no benefit.

Instead, patients rely on physical therapy, occupational therapy, speech therapy, and exercise to manage symptoms. However, these approaches can only slow disease progression to a limited extent.

“IBM is a tremendously debilitating disease, which drastically and irreversibly reduces quality of life,” said Paula Eichenbrenner, Executive Director of The Myositis Association.

She added, “The lack of disease-modifying treatment options places more burden on IBM families as they must help their loved ones manage anxiety about inevitable muscle loss and the feeling of being trapped with this rare, catastrophic disease.”

Ulviprubart: A first-in-class therapy

Abcuro’s ulviprubart, also known as ABC08, is an antibody that targets killer cell lectin-like receptor G1 (KLRG1).

If successful, it could become the first approved drug for IBM. Abcuro expects to have results from the MUSCLE trial in the first half of next year.

The trial, which enrolled 230 patients last year, is testing two doses of ulviprubart administered via subcutaneous injection against a placebo.

Researchers will evaluate safety over 20 weeks and track changes in IBM Functional Rating Scales (IBMFRS) over 76 weeks.

Funding to support manufacturing and commercialization

Alongside funding the trial, the new investment will also support expanding manufacturing capabilities and other pre-commercial activities in 2024, according to Abcuro CEO Alex Martin.

“This funding validates our vision for the potential that ulviprubart may have as a novel treatment for progressive and devastating diseases mediated by highly cytotoxic T-cells,” Martin stated.

Abcuro’s previous Series B funding round, completed in August 2023, raised US $155 million. The new Series C round further strengthens the company’s financial position as it moves closer to commercialization.

Potential beyond IBM

In addition to IBM, ulviprubart is also being explored for other T-cell-driven diseases, including:

• T-cell large granular lymphocytic leukemia (T-LGLL) – a rare blood cancer that causes anemia and neutropenia, often requiring blood transfusions.
• T-cell and NK-cell associated lymphomas – cancers affecting the immune system.