PARIS, September 26, 2022–(COMMERCIAL WIRE)–Regulatory news:
ACTICOR BIOTECH (ISIN: FR0014005OJ5 – ALACT), a clinical-stage biopharmaceutical company developing an innovative treatment for acute thrombotic diseases, including ischemic stroke, today announces the enrollment of the first patient in the United States in its Phase 2 study/ 3 ACTISAVE registry evaluating glenzocimab in patients with acute ischemic stroke.
This first American patient was enrolled at the CHI Memorial Stroke and Neuroscience Center, Chattanooga, Tennessee, by the Dr. Ruchir A. Shah, MD declaring: “I am very pleased with this first inclusion in the United States in the ACTISAVE study. Glenzocimab has significant potential for improvement in patients with ischemic stroke, particularly those undergoing mechanical thrombectomy. We urgently need new drugs in this indication, and glenzocimab has an innovative and promising mechanism of action on recanalization and downstream microcirculation. The Chattanooga CHI Memorial is a state-of-the-art stroke unit, largely dedicated to research, receiving a medically unprecedented 1,400 stroke patients a year. »
ACTICOR had obtained an IND for this study1 of the Food and Drug Administration (FDA) in November 2021 and had begun recruitment in Europe in the third quarter of 2021. The study currently has 130 patients.
The clinical trial plans to treat 1,000 patients in approximately 80 centers in the United States, Europe (France, Germany, Belgium, Spain, Slovakia, Denmark, Czech Republic), Great Britain and Israel. A first futility analysis is planned after the inclusion of the first 200 patients to confirm the initial hypotheses.
Dr. Yannick PLETAN, Deputy CEO and Medical Director of Acticor Biotech, adds: “The opening of the first American centers, in addition to those already active in Europe, marks an important new step for our phase 2/3 ACTISAVE study. The cumulative incidence of ischemic stroke in the United States, Europe, Japan and China will approach 4 million patients in 2026two ; this demonstrates the urgent need for an effective treatment to deal with this important public health problem with a strong social and economic impact. »
In July 2022, Acticor Biotech obtained Priority Medicines (PRIME) status from the European Medicines Agency for glenzocimab in the treatment of stroke, thus recognizing the potential clinical benefit of glenzocimab and its relevant response to the unmet medical need in this pathology. As efficacy data is a secondary endpoint of the Phase 1b/2a ACTIMIS study, glenzocimab may not be eligible for Breakthrough Therapy status despite significant data on mortality and reduction in cerebral hemorrhage. However, these data and the inclusion of patients in the United States will allow Acticor Biotech to apply for “Fast Track” status with the FDA in the coming weeks.
ACTIVATE (NCT05070260) is a multinational, adaptive, multicenter, randomized, double-blind, placebo-controlled, parallel-group, Phase 2/3 study evaluating the safety and efficacy of a single dose of glenzocimab used in combination with standard of care (thrombolysis +/- thrombectomy) of acute ischemic cerebrovascular accident (CVA).
About ACTICOR BIOTECH
Acticor Biotech is a clinical-stage biopharmaceutical company developing glenzocimab, an innovative drug for the treatment of cardiovascular emergencies, including ischemic stroke.
In May 2022, Acticor Biotech presented at ESOC the positive results of its phase 1b/2a study, ACTIMIS, confirming the safety profile and showing a reduction in mortality and intracerebral hemorrhage in the group treated with glenzocimab in stroke patients. The efficacy of glenzocimab is currently being evaluated in an international phase 2/3 study, ACTISAVE, which will include 1,000 patients. In July 2022, Acticor Biotech obtained PRIME status from the European Medicines Agency (EMA) for glenzocimab in the treatment of stroke. This appointment will allow the company to strengthen its interactions and gain early dialogue 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 Armesa Foundation) and has been listed on Euronext Growth Paris since November 2021 (ISIN: FR0014005OJ5 – ALACT).
For more information visit: www.actor-biotech.com
1 Investigational New Drug Application
two AIS Epidemiology Forecast from Global Data to 2022
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