Acticor Biotech is shifting its focus to the treatment of myocardial infarction with glenzocimab, a humanized monoclonal antibody fragment targeting the GPVI platelet receptor. This strategic decision follows consultation with international experts who affirmed glenzocimab's potential in treating ST-Elevation Myocardial Infarction (STEMI). The company is currently conducting the LIBERATE phase 2b study and planning a new phase 2 trial named GLORIA to further evaluate the drug's efficacy.
LIBERATE: Phase 2b Study Details
The LIBERATE study is a phase 2b, randomized, double-blind trial involving over 212 patients with STEMI undergoing percutaneous coronary intervention (PCI). The primary objective is to evaluate the safety and efficacy of glenzocimab 1000 mg compared to placebo in reducing myocardial infarct size 90 days post-event. This study is being conducted in partnership with the University of Birmingham (UK), leveraging clinical expertise from the Institute of Cardiovascular Sciences and University Hospitals Birmingham NHS Foundation Trust. Patient recruitment began in January 2024 at Queen Elizabeth Hospital in Birmingham and Northern General Hospital in Sheffield. As of the latest update, 27 patients have been recruited, with study results expected in Q4 2026.
GLORIA: Upcoming Phase 2 Study
Acticor Biotech is also preparing a new phase 2 study, GLORIA, designed to evaluate glenzocimab in the treatment of myocardial infarction. This randomized, double-blind study aims to enroll around 300 patients with STEMI upon emergency admission to cardiac intensive care units. Similar to LIBERATE, the primary objective of GLORIA is to assess the efficacy of glenzocimab in reducing the surface area of myocardial infarct at Day 90 post-PCI, along with safety. The study plans to explore several dose levels and optimize the administration method to align with the emergency procedure's timeframe. The goal is to gather comprehensive clinical and regulatory data to support a phase 3 registration as early as 2027.
Strategic Rationale and Market Context
Gilles Avenard, CEO and founder of Acticor Biotech, emphasized the significant unmet medical need in managing microvascular thrombosis, a major contributor to severe complications in myocardial infarction. He noted that myocardial infarction remains a leading cause of death worldwide, with STEMI accounting for 30-40% of the 7 to 9 million annual deaths. Yannick Pletan, Chief Medical Officer and Chief Operating Officer of Acticor Biotech, highlighted the advantages of focusing on myocardial infarction, including greater homogeneity in STEMI patients, easier diagnosis without prior imaging, and better access to emergency services compared to stroke. Patient recruitment for GLORIA could commence in Q1 2025, contingent on the company's financing and the outcome of its receivership procedure.
