Abcuro lands US$200M to advance IBM therapy

USA—American biotech company Abcuro has successfully raised $200 million to advance its innovative treatment for inclusion body myositis (IBM), a challenging and rare condition.

This funding, led by New Enterprise Associates (NEA), is designated for developing and further testing Abcuro’s monoclonal antibody, ulviprubart.

 It will play a crucial role in progressing the treatment through its ongoing clinical evaluation.

Abcuro’s primary focus is to complete the Phase II/III MUSCLE clinical trial, which is designed to assess the safety and efficacy of ulviprubart over a 76-week period, followed by a four-week safety follow-up.

If the trial results are positive, the company plans to file a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) later this year.

Additionally, part of the new capital will be allocated to expanding manufacturing capabilities and supporting various pre-commercial activities, ensuring the company is well-prepared for the next development phase.

Inclusion body myositis (IBM) is a rare autoimmune disorder characterized by chronic muscle inflammation, which leads to progressive muscle weakness.

 Over time, this condition can cause significant difficulties with everyday tasks, including swallowing and fine motor skills such as gripping or typing.

Unlike many other autoimmune diseases, IBM is typically resistant to standard treatments like corticosteroids and immunosuppressive drugs.

As a result, patients currently rely on supportive measures, such as physical, occupational, and speech therapies, as well as exercise programs, to manage their symptoms.

The IBM research space has historically presented significant challenges.

For example, Novartis previously investigated an experimental antibody called bimagrumab in the Phase IIb/III RESILIENT trial.

Despite high expectations, the trial did not show functional benefits for patients with IBM, leading to the program’s termination in 2016.

Later, Novartis licensed bimagrumab to Versanis Bio, which Eli Lilly subsequently acquired in July 2023 for US$1.9 billion.

In contrast, Abcuro is employing a more targeted approach with its drug ulviprubart, which focuses on the killer cell lectin-like receptor G1 (KLRG1). The goal is to deplete the toxic T cells that continually attack muscle tissue in IBM patients.

Additionally, ulviprubart is being assessed in a Phase I/II study for T cell-large granular lymphocytic leukaemia (T-LGLL), a rare blood cancer.

This latest funding milestone builds upon Abcuro’s previous achievements; the company raised US$155 million in a Series B round in August 2023, co-led by Redmile Group and Bain Capital Life Sciences.

With plans for regulatory filing in 2026, Abcuro is optimistic that its efforts may ultimately lead to the first FDA-approved treatment specifically for IBM, offering hope to patients who have long struggled with this debilitating disease. 

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