The Series C funding round was led by New Enterprise Associated (NEA). Credit: sesame via Getty Images.

US-based biotech Abcuro has raised $200m to advance the development of its monoclonal antibody ulviprubart in the rare muscle disease called inclusion body myositis (IBM).

The funding round, led by New Enterprise Associates (NEA), will be used to complete the Phase II/III MUSCLE clinical trial (NCT05721573) of ulviprubart. Assuming positive results from the study, Abcuro said it plans to file a biologics licence application (BLA) and will use some of the funds to support the expansion of manufacturing capabilities and “other pre-commercial activities this year”.

Abcuro completed patient enrolment in the MUSCLE trial in June 2024, and topline data is expected in H1 2026, said Abcuro’s chief medical officer H. Jeffery Wilkins in a previous announcement. The MUSCLE study compares two dose levels of ulviprubart with placebo at 76 weeks in subjects with IBM, followed by a four-week safety follow-up period.

IBM is a group of autoimmune diseases that involve inflammation of the muscles or associated tissues. The inflammation causes muscle weakness that may worsen over time, leading to difficulty in swallowing and weak wrists or fingers. There are currently no US Food and Drug Administration (FDA)-approved treatments specifically for IBM. Patients are generally managed using physical therapy, occupational therapy, speech therapy, and exercise. Despite being an autoimmune disorder, the disease is generally unresponsive to corticosteroids and immunosuppressive drugs.

The IBM research space is sparse, with companies like Novartis facing hurdles in developing effective treatments. Novartis tested investigational antibody bimagrumab in the Phase IIb/III RESILIENT trial (NCT01925209), but the drug failed to show functional benefits in subjects with IBM. This led to the programme’s termination in 2016. Novartis later licensed bimagrumab to Versanis Bio – the subject of a $1.9bn Eli Lilly acquisition in July 2023.

Abcuro’s candidate works by targeting killer cell lectin like receptor G1 (KLRG1). The goal is to deplete the highly toxic T cells that chronically attack the muscle tissue in patients with IBM. Abcuro is also testing ulviprubart in a Phase I/II study (NCT05532722) in T cell-large granular lymphocytic leukaemia (T-LGLL), a blood cancer that occurs when certain T cells and natural killer cells mutate.

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This latest funding builds on the $155m Abcuro raised in a Series B round co-led by Redmile Group and Bain Capital Life Sciences in August 2023. The company outlined then that it anticipates a regulatory approval filing in 2026.