Regulatory News:
The University of Birmingham and Acticor Biotech (Paris:ALACT)
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 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.
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
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
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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version on businesswire.com: https://www.businesswire.com/news/home/20240207550995/en/
For media enquiries please contact Tim Mayo, Press Office,
University of Birmingham, Tel: +44 (0)7920 405040: email:
t.mayo@bham.ac.uk
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
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