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Acticor Biotech Announces the First Patient in ACTISAVE, its adaptive Phase 2/3 Efficacy Study in Acute Ischemic Stroke

Paris, October 13, 2021 – Acticor Biotech, a clinical stage biotechnology company working on treatment for the acute phase of thrombotic diseases, today announces that it started at the end of September 2021 the recruitment in ACTISAVE, its international phase 2/3 adaptive study on glenzocimab (ACT017), a novel humanized monoclonal antibody fragment for use in patients with acute ischemic stroke.

ACTISAVE (NCT05070260) is an adaptive phase 2/3, multinational, randomized, double-blind, multicenter, placebo-controlled, parallel group, single dose, efficacy and safety study of glenzocimab used as an add-on to standard of care therapy for acute ischemic stroke. 

“We are very excited to have included the first patient in ACTISAVE, the new adaptive phase 2/3 study in Acute Ischemic Stroke using glenzocimab. Favourable safety and bounding of the bleeding risk shown in the first part of the ACTIMIS dose escalating study support the potential of this novel first-in-class treatment in AIS. I am particularly grateful to my team at Pellegrin Hospital in Bordeaux – France for working with such dedication in the context of COVID-19.” says Prof. Igor Sibon, Pellegrin Hospital in Bordeaux, Coordinating Investigator in France for ACTISAVE.

The primary objective of ACTISAVE, where patients are randomized to either 1000mg glenzocimab or its matching placebo, is to evaluate the efficacy of glenzocimab in addition to standard of care, thrombolysis only or thrombolysis plus thrombectomy, with specific focus on the modified Rankin Scale score (mRS) at Day 90. Eight countries will be involved in including a total of 1000 patients. An initial futility analysis is planned after 200 patients have been enrolled.

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