Newton, Massachusetts, November 13, 2023 – Abcuro, Inc., a clinical-stage biotechnology company developing therapies for the treatment of autoimmune diseases and cancer through precise modulation of cytotoxic T and NK cells, today announced initiation of Part B of the registrational Phase 2/3 MUSCLE clinical study, an ongoing clinical trial of ulviprubart (ABC008) for the treatment of inclusion body myositis (IBM). The decision to advance to Part B and continue the trial without modification was made after positive review and recommendation by an independent Data Safety Monitoring Board (DSMB).
“Advancing to Part B of the Phase 2/3 MUSCLE clinical trial, combined with the positive DSMB review of the data to date, is an important milestone for both Abcuro and IBM patients. There are currently no therapeutic options to treat IBM, and we believe in the potential of ulviprubart (ABC008), a first-in-class anti-KLRG1 antibody product candidate, to truly transform the lives of patients,” said H. Jeffrey Wilkins, M.D., Chief Medical Officer of Abcuro.
The Phase 2/3 MUSCLE clinical trial (NCT05721573) is a randomized, double-blind, placebo-controlled, parallel multicenter trial evaluating ulviprubart (ABC008) in patients with IBM. The three-part, registrational Phase 2/3 clinical trial will enroll more than 200 patients across 30 global sites. Part A of the trial involved enrollment of a sentinel safety cohort in which subjects underwent safety and tolerability review by a DSMB after 20 weeks of treatment. Following a positive DSMB review, the trial is now progressing to Part B of the trial, with the main purpose being the evaluation of the efficacy, safety, and tolerability of two dose levels of ulviprubart (ABC008) (0.5 mg/kg and 2.0 mg/kg) compared with placebo at 76 weeks in subjects with IBM. Part C of the trial will provide pharmacodynamic follow-up for subjects who discontinue treatment.
About Ulviprubart (ABC008)
Ulviprubart (ABC008) is a first-in-class anti-KLRG1 antibody product candidate capable of selectively depleting highly cytotoxic T cells, while sparing naïve, regulatory and central memory T cells. Ulviprubart (ABC008) is designed to treat diseases mediated by highly cytotoxic T cells, including the autoimmune muscle disease inclusion body myositis (IBM), T cell large granular lymphocytic leukemia (T-LGLL), and mature T cell malignancies. The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have each granted Orphan Drug Designation to ulviprubart (ABC008) for the treatment of IBM.
About Inclusion Body Myositis (IBM)
IBM is an autoimmune disease in which highly cytotoxic T cells chronically attack muscle tissue leading to progressive weakness and limb muscle atrophy. Patients progressively lose muscle function, including loss of grip and dexterity and loss of mobility. There are currently no available disease-modifying treatment options for IBM. Based on published epidemiology literature, about 50,000 patients suffer from IBM across the US and Europe.
Abcuro is a clinical stage biotechnology company developing first-in-class immunotherapies for the treatment of autoimmune diseases and cancer through precise modulation of highly cytotoxic T and NK cells. The company’s lead program is ulviprubart (ABC008) and is currently in clinical trials for inclusion body myositis (IBM) and T cell large granular lymphocytic leukemia. For more information, visit us on LinkedIn and at abcuro.com.