ACTICOR Adapts Its ACTISAVE Clinical Study to Prepare the Registration of Glenzocimab for the Treatment of Stroke
15 September 2023
Acticor Biotech (ISIN: FR0014005OJ5 - ALACT), a clinical-stage biopharmaceutical company developing glenzocimab, an innovative drug for treating cardiovascular emergencies, has announced its refined development plan for Acute Ischemic Stroke (AIS) aimed at obtaining glenzocimab's registration in Europe and the United States.
The international phase 2/3 study, ACTISAVE (NCT05070260), is an adaptive, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial. It assesses the safety and efficacy of a single dose of glenzocimab in combination with the reference treatment (thrombolysis with or without mechanical thrombectomy) for acute ischemic stroke.
Following consultations with European (EMA) and US (FDA) regulatory agencies and in agreement with ACTISAVE's scientific committee, Acticor Biotech has chosen to modify the study's dual primary endpoint to a single endpoint, specifically the reduction in the number of patients who either died or experienced severe disability due to the stroke (mRS score 4-6 at 90 days). This adjustment to the primary endpoint will reduce the study's size from the initially planned 1,000 patients to 400, allowing for clinical results to be obtained as early as the second quarter of 2024.
About ACTICOR BIOTECH
Acticor Biotech is a clinical-stage biopharmaceutical company that originated from INSERM (the French National Institute of Health and Medical Research). It focuses on developing an innovative treatment for cardiovascular emergencies, including ischemic stroke.
The positive outcomes from its Phase 1b/2a study, ACTIMIS, affirmed the safety profile and revealed a reduction in mortality and intracerebral hemorrhage among glenzocimab-treated patients with stroke. The effectiveness of glenzocimab is currently under evaluation in the international Phase 2/3 study, ACTISAVE. In July 2022, Acticor Biotech was granted "PRIME" status by the European Medicines Agency (EMA) for glenzocimab in stroke treatment. This designation facilitates the company's interactions and early dialogues with regulatory authorities.
Acticor Biotech is backed by a group of European and international investors, including Mediolanum farmaceutici, Karista, Go Capital, Newton Biocapital, CMS Medical Venture Investment (HK) Limited, A&B (HK) Limited, Anaxago, and the Armesa foundation. Acticor Biotech has been listed on Euronext Growth Paris since November 2021 (ISIN: FR0014005OJ5 – ALACT).