PARIS--(BUSINESS WIRE)--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.
