The University of Birmingham and Acticor Biotech announce the First Patient treated in LIBERATE, first clinical trial evaluating glenzocimab for heart attack

University of Birmingham and Acticor Biotech News Release
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The University of Birmingham and Acticor Biotech announce the First Patient treated in

LIBERATE, first clinical trial evaluating glenzocimab for heart attacks

February 7, 2024, the University of Birmingham and Acticor Biotech are proud to announce the first patient 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 cutting-edge clinical research sites, namely 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 24^th 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.

Doctor 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 trial said: “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 declared: “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.”

Results of the LIBERATE clinical trial are expected by Q4 2025

ENDS

For media enquiries please contact Tim Mayo, Press Office, University of Birmingham, Tel: +44 (0)7920 405040: email: t.mayo@bham.ac.uk

Notes to editor:

• 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 6,500 international students from over 150 countries.
• The University of Birmingham is a 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 five 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
  • Sandwell and West Birmingham Hospitals NHS Trust
  • West Midlands Academic Health Science Network

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 (link to the publication).

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 (link to the publication) 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).

 

For more information, visit: www.acticor-biotech.com

 

ACTICOR Contacts

ACTICOR BIOTECH Gilles AVENARD, MD CEO and Founder gilles.avenard@acticor-biotech.com T. : +33 (0)6 76 23 38 13   Sophie BINAY, PhD General Manager and CSO Sophie.binay@acticor-biotech.com T. : +33 (0)6 76 23 38 13

NewCap Mathilde BOHIN Investor Relations acticor@newcap.eu T. : +33 (0)1 44 71 94 95

NewCap Arthur ROUILLÉ Media Relations acticor@newcap.eu T. : +33 (0)1 44 71 00 15

Disclaimer

This press release contains certain forward-looking statements concerning Acticor Biotech and its business. Such forward-looking statements are based on assumptions that Acticor Biotech considers to be reasonable. However, there can be no assurance that such forward-looking statements will be verified, which statements are subject to numerous risks, including the risks set forth in the Document de référence registration document as approved by the Autorité des marchés financiers under number R. 22-011 on 26 April 2022 and to the development of economic conditions, financial markets and the markets in which Acticor Biotech operates. The forward-looking statements contained in this press release are also subject to risks not yet known to Acticor Biotech or not currently considered material by Acticor Biotech. The occurrence of all or part of such risks could cause actual results, financial conditions, performance or achievements of Acticor Biotech to be materially different from such forward-looking statements. 

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