October 13th, 2021, Acticor Biotech issued a press release, which is summarized as follows:
Acticor Biotech 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.
In July 2021, Acticor Biotech announced the end of recruitment for ACTIMIS, its phase 1b/2a dose escalation and safety study in 160 patients (NCT03803007); the target dose of 1000mg was reached and confirmed by the Drug Safety Monitoring Board (DSMB). No safety issues were detected by the DSMB at any point during this study. The complete results of ACTIMIS are expected by the first quarter 2022.
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