The UK Regulatory Agency (MHRA) Approved the Protocol of LIBERATE Study, the First Clinical Trial Evaluating Glenzocimab for Heart Attacks
08 September 2023 - 2:00AM
Business Wire
September 7th, 2023, the University of Birmingham and Acticor
Biotech (Paris:ALACT) announce the full regulatory approval of
LIBERATE clinical study.
In 2021, 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
University has received full regulatory approvals to initiate the
study.
This new clinical trial is based on a long-standing
collaboration between Acticor Biotech and the University of
Birmingham. The publication in August of a scientific paper from Dr
Mark Thomas entitled: “Amplified inhibition of atherosclerotic
plaque-induced platelet activation by glenzocimab with dual
antiplatelet therapy “ (link to the publication) in the Journal of
Thrombosis and Haemostasis, reinforced the mode of action of
glenzocimab and its major role as an antithrombotic drug.
The randomised, double-blind Phase 2b LIBERATE study will
recruit more than 200 patients suffering from a ST-elevation
myocardial infarction (STEMI) and planned for a percutaneous
coronary intervention. The study aims to assess the safety and the
efficacy of glenzocimab 1000 mg versus placebo to reduce the
myocardial infarct size at Day 90 post-treatment. The trial will be
conducted in two acute care hospitals in the UK: the Queen
Elizabeth Hospital, Birmingham and the Northern General Hospital,
Sheffield. Patient recruitment is expected to start by the end of
2023.
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: “Our recent
studies of glenzocimab at the University of Birmingham have just
been published – these explain the cellular mechanisms for why it
is highly effective at reducing “blood stickiness”, particularly
when combined with existing medications. We are very pleased to
receive regulatory approval to launch the LIBERATE clinical trial
to investigate whether glenzocimab can reduce the type of blood
clotting that causes heart damage during heart attacks. This
exciting collaboration with Acticor has the potential to benefit
our patients in Birmingham and Sheffield, and across the
world.”
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: “This new
drug looks extremely promising and we are excited to be within
sight of beginning recruitment for this important trial”
Yannick Pletan, Chief Medical Officer, and General Manager of
Acticor Biotech declared: “Glenzocimab has already delivered
very promising results in the treatment of acute ischemic stroke
and we hope to confirm its therapeutics potential in other
cardiovascular emergency indications. LIBERATE phase 2b study
extends glenzocimab development programme to myocardial infarction.
We are delighted to collaborate with all the teams involved, the
University of Birmingham particularly, sponsor of this study, to
extend the therapeutic field of glenzocimab.”
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 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.
Acticor Biotech is developing glenzocimab (ACT017), a humanized
monoclonal antibody (mAb) fragment directed against a novel target
of major interest, platelet glycoprotein VI (GPVI). Glenzocimab
inhibits platelet binding to the thrombus without affecting
physiological hemostasis, thereby limiting the bleeding risk,
particularly in the brain.
The positive results from its Phase 1b/2a study, ACTIMIS,
confirmed the safety profile and showed a reduction in mortality
and intracerebral hemorrhage in the glenzocimab-treated group in
patients with stroke. The efficacy of glenzocimab is now being
evaluated in ACTISAVE, an international Phase 2/3 study. 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 (Karista, Go Capital, Newton Biocapital,
CMS Medical Venture Investment (HK) Limited, A&B (HK) Limited,
Mirae Asset Capital, Anaxago, Primer Capital, Mediolanum
farmaceutici 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230907480665/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 / Quentin MASSÉ 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
Acticor Biotech (EU:ALACT)
Historical Stock Chart
From Apr 2024 to May 2024
Acticor Biotech (EU:ALACT)
Historical Stock Chart
From May 2023 to May 2024