- 27 patients recruited in the phase 2b LIBERATE study
evaluating glenzocimab in the treatment of ST-Elevation Myocardial
Infarction (STEMI)
- Preparation of a new phase 2 study, GLORIA, evaluating
glenzocimab in angioplasty for STEMI
Regulatory News:
ACTICOR BIOTECH (FR0014005OJ5 - ALACT), a clinical stage
biopharmaceutical company developing glenzocimab, an innovative
drug for the treatment of cardiovascular emergencies, today
provides an update on its clinical developments evaluating
glenzocimab in the treatment of myocardial infarction.
Gilles AVENARD, Chief Executive Officer and founder of
Acticor Biotech, comments: “Myocardial infarction remains a
major cause of death worldwide, accounting for 7 to 9 million
deaths per year, of which 30 to 40% are caused by ST-Elevation
Myocardial Infarction (STEMI). This severe type of heart attack,
caused by the complete blockage of a coronary artery, results in
significant damage to the heart muscle. Despite advances in current
treatments such as angioplasty and antithrombotics, there remains
an unmet medical need for more effective management of
microvascular thrombosis, which is responsible for severe
complications. Acticor Biotech is currently conducting a phase 2b
study, LIBERATE, in partnership with the University of Birmingham,
UK, to evaluate the efficacy and safety of glenzocimab in reducing
infarct size and preventing microvascular complications. Confident
of glenzocimab's potential, we are considering a clinical
development plan in this indication, in particular a new Phase 2
clinical trial, GLORIA.”
Yannick PLETAN, Chief Medical Officer and Chief Operating
Officer of Acticor Biotech, confirmed: “The international
experts consulted following the results in stroke are unanimous in
affirming that glenzocimab retains all its interest in myocardial
infarction due to its innovative mode of action and greater
homogeneity in STEMI patients. The cause of an infarction remains
in the rupture of a coronary atherosclerotic plaque, diagnosis does
not require prior imaging, and access to emergency services is
greater than for a stroke. All these factors militate in favor of
the continued development of glenzocimab in this indication.”
LIBERATE: A phase 2b study evaluating glenzocimab in the
treatment of myocardial infarction
The LIBERATE phase 2b, randomized and double-blind study will
include more than 212 patients suffering from ST-Elevation
Myocardial Infarction (STEMI) who are scheduled to undergo
percutaneous coronary intervention (PCI). The study’s primary
objective is to assess the safety and efficacy of glenzocimab 1000
mg compared to placebo, in reducing the size of the myocardial
infarction 90 days post-event.
This study is being conducted in partnership with the University
of Birmingham (UK), with clinical experts from the Institute of
Cardiovascular Sciences and University Hospitals Birmingham NHS
Foundation Trust. The two leading clinical research sites, Queen
Elizabeth Hospital in Birmingham and Northern General Hospital in
Sheffield, have been actively recruiting patients since January
2024.
To date, 27 patients have been recruited, and study results are
expected in Q4 of 2026.
GLORIA: A phase 2 study evaluating glenzocimab in myocardial
infarction treatment
A new phase 2 study GLORIA, randomized and double-blind, is
being prepared to evaluate glenzocimab in the treatment of
myocardial infarction. The study will enroll around 300 patients
suffering from STEMI upon emergency admission to cardiac intensive
care units.
The study’s primary objective is likewise to assess the efficacy
of glenzocimab for reducing the surface of myocardial infarct at
Day 90 post PCI (Percutaneous Coronary Intervention), as well as
safety. The study plans to test several dose levels and optimize
the mode of administration to suit the time required for this
emergency procedure.
The aim of launching this second study, which could be promoted
by the Company, is to provide all the clinical and regulatory
elements required for a phase 3 registration as early as 2027,
while evolving the product's mode of administration to facilitate
the next stage of development and, later, adoption by
clinicians.
Patient recruitment could begin in Q1 2025, subject to the
Company's financing or the continuation of the project as envisaged
in the receivership procedure.
About ACTICOR BIOTECH
ACTICOR BIOTECH, a clinical-stage biopharmaceutical company
founded in 2013 from the work of INSERM, is developing glenzocimab,
a humanized monoclonal antibody fragment (fab) targeting the GPVI
platelet receptor for the treatment of cardiovascular emergencies
and acute thrombotic diseases.
The main clinical indication being evaluated is acute ischemic
stroke, due to the strong need for safer treatments, particularly
those that do not increase the risk of bleeding, and its high
incidence. In three international clinical trials involving over
600 stroke patients, no significant impact on neurological
improvement (mRS score at 3 months) was demonstrated, with the
exception of a sub-population of patients with intracerebral
haemorrhage, where mortality was significantly reduced by a factor
of 3 (p=0.035) (Mazighi et al. 2024).
LIBERATE, a Phase 2 clinical trial in the acute phase of
myocardial infarction (STEMI), is currently being recruited through
an academic partnership with the University of Birmingham (UK).
This study aims to demonstrate the efficacy of glenzocimab in
reducing the size of myocardial infarction, a critical factor for
long-term cardiac function.
In all, more than 800 subjects were included in the clinical
trials, over 400 of whom were exposed to glenzocimab without safety
concerns.
The use of glenzocimab in thrombotic diseases is covered by 3
patent families, with an expiry date in 2036 for the first family.
ACTICOR BIOTECH also has the right to develop a biomarker for
stroke patients.
Acticor Biotech is backed 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)
and has been listed on Euronext Growth Paris since November 2021
(ISIN: FR0014005OJ5 - ALACT).
For further information, visit: www.acticor-biotech.com
Disclaimer
This press release contains forward-looking statements with
respect to Acticor Biotech and its business. Acticor Biotech
believes that these forward-looking statements are based on
reasonable assumptions. However, no assurance can be given that the
expectations expressed in such forward-looking statements will
prove to have been correct, as they are subject to risks, including
those described in the Universal Registration Document as filed
with the Autorité des marchés financiers on July 9, 2024, and to
changes in 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 that are
unknown to Acticor Biotech or that Acticor Biotech does not
currently consider material. The occurrence of some or all of these
risks could cause Acticor Biotech's actual results, financial
condition, performance or achievements to differ materially from
those expressed in the forward-looking statements.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20241011112282/en/
ACTICOR BIOTECH Gilles AVENARD, MD CEO and Founder
gilles.avenard@acticor-biotech.com
Sophie BINAY, PhD General Manager and CSO
Sophie.binay@acticor-biotech.com
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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