The first patient has been treated in the LIBERATE clinical study to evaluate glenzocimab efficacy in myocardial infarction.
In 2022, the University of Birmingham and Acticor Biotech signed a partnership agreement to evaluate glenzocimab efficacy in myocardial infarction in a new clinical trial called LIBERATE.
Having obtained full regulatory approval in August 2023, two clinical research sites, the Queen Elizabeth Hospital in Birmingham and the Northern General Hospital in Sheffield, are involved in the study. The Queen Elizabeth Hospital in Birmingham opened to recruitment on 24th January 2024. It is expected that the Northern General Hospital in Sheffield will also open to recruitment by the end of February 2024.
The LIBERATE study, a randomized, double-blind Phase 2b trial, will enrol over 200 patients diagnosed with ST-elevation myocardial infarction (STEMI) and scheduled for percutaneous coronary intervention. The primary objective of the study is to evaluate both the safety and efficacy of glenzocimab at a dosage of 1000 mg compared to a placebo, specifically focusing on the reduction of myocardial infarct size at Day 90 post-treatment.
This is the first time worldwide that this class of medication has been investigated in patients with heart attacks, after showing great promise in patients with stroke.
Dr Mark Thomas
Dr Mark Thomas, Associate Professor of Cardiology at the University of Birmingham and Honorary Consultant Cardiologist, who designed the trial and led its development, said:
“We are very happy to have started recruiting into the LIBERATE clinical trial. This is the first time worldwide that this class of medication has been investigated in patients with heart attacks, after showing great promise in patients with stroke.
"We are grateful to our patients for helping us in our mission to find new treatments that may help to reduce the damage done by heart attacks.”
Professor Robert Storey, Professor of Cardiology at the University of Sheffield and Honorary Consultant Cardiologist and Director of the Cardiovascular Research Unit at Northern General Hospital, said:
“We are very pleased to now recruit patients in the LIBERATE clinical trial. This study is exploring the potential of glenzocimab in reducing the type of blood clotting responsible for heart damage during heart attacks. This exciting collaboration with University of Birmingham and Acticor Biotech holds the potential to bring significant benefit to people suffering from a heart attack.”
Professor Jon Townend, Consultant Cardiologist at University Hospitals Birmingham, Honorary Professor of Cardiology in the Institute of Cardiovascular Sciences at the University of Birmingham, and Chief Investigator of the trialsaid:
“We have entered the operational phase of the trial, and I extend my gratitude to the entire team in Birmingham and Sheffield for their outstanding efforts in managing patient recruitment in these critical emergency care settings, as well as for gathering qualitative data for subsequent analysis.”
Adeline Meilhoc, Head of Global Clinical Development of Acticor Biotech said:
“We are delighted to witness the operational start of the study, and we reiterate our complete confidence in our partners as crucial contributors of its success. Acticor Biotech is dedicated to advancing treatments for the acute phase of thrombotic diseases. Glenzocimab application in ST-segment elevation myocardial infarction (STEMI) represents a significant focal point for Acticor Biotech’s commitment to medical advancement.”
For media enquiries please contact Tim Mayo, Press Office, University of Birmingham, tel: +44 (0)7815 607 157.
The University of Birmingham is ranked amongst the world’s top 100 institutions. Its work brings people from across the world to Birmingham, including researchers, teachers and more than 8,000 international students from over 150 countries.
The University of Birmingham is a founding member of Birmingham Health Partners (BHP), a strategic alliance which transcends organisational boundaries to rapidly translate healthcare research findings into new diagnostics, drugs and devices for patients. Birmingham Health Partners is a strategic alliance between seven organisations who collaborate to bring healthcare innovations through to clinical application:
University of Birmingham
University Hospitals Birmingham NHS Foundation Trust
Birmingham Women's and Children's Hospitals NHS Foundation Trust
Aston University
The Royal Orthopaedic Hospital NHS Foundation Trust
Sandwell and West Birmingham Hospitals NHS Trust
West Midlands Academic Health Science Network
Birmingham and Solihull Mental Health NHS Foundation Trust
About LIBERATE
In 2022, the University of Birmingham and Acticor Biotech signed a partnership agreement to evaluate glenzocimab efficacy in myocardial infarction in a new clinical trial called LIBERATE. The LIBERATE study is a randomized, double-blind Phase 2b trial, will enroll over 200 patients diagnosed with ST-elevation myocardial infarction (STEMI) and scheduled for percutaneous coronary intervention. The primary objective of the study is to evaluate both the safety and efficacy of glenzocimab at a dosage of 1000 mg compared to a placebo, specifically focusing on the reduction of myocardial infarct size at Day 90 post-treatment.
Dr Mark Thomas, co-investigator of LIBERATE study, authored a publication in the Journal of Thrombosis and Haemostasis in August 2023 to present the mode of action of glenzocimab and its major role as an antithrombotic drug in STEMI.
About ACTICOR BIOTECH Acticor Biotech is a clinical stage biopharmaceutical company, a spin-off from INSERM (the French National Institute of Health and Medical Research), which is aiming to develop an innovative treatment for cardiovascular emergencies, including ischemic stroke.
The positive results of the phase 1b/2a study, ACTIMIS, published in January 2024 in the Lancet Neurology confirmed the safety profile of glenzocimab and showed a reduction in mortality and intracerebral hemorrhage in the glenzocimab-treated group of stroke patients. These results were confirmed by a post-hoc analysis of brain imaging at 0 and 24 hours using artificial intelligence (Brainomix, UK). This independent analysis confirmed the reduction in the number and volume of intracerebral lesions in patients treated with glenzocimab.
The efficacy of glenzocimab is now being analyzed in an international Phase 2/3 study, ACTISAVE, with clinical results expected in Q2 2024.
In July 2022, Acticor Biotech was granted "PRIME" status by the European Medicines Agency (EMA) for glenzocimab in the treatment of stroke. This designation will allow the company to strengthen its interactions and obtain early dialogues with regulatory authorities. Acticor Biotech is supported by a panel of European and international investors (Mediolanum farmaceutici, Karista, Go Capital, Newton Biocapital, CMS Medical Venture Investment (HK) Limited, A&B (HK) Limited, Anaxago, and the Armesa foundation). Acticor Biotech is listed on Euronext Growth Paris since November 2021 (ISIN: FR0014005OJ5 – ALACT).
