【Acticor Biotech-Product ACT017】Acticor Biotech Announces the Completion of Enrollment in Actimis, its Key Phase 1B/2A Safety Study

Partner News

July 1st, 2021, Acticor Biotech issued a press release, which is summarized as follows:

Acticor Biotech today announces the end of recruitment in ACTIMIS, its phase 1b/2a study with glenzocimab (ACT017), a novel humanized monoclonal antibody fragment for use in patients with acute ischemic stroke.

ACTIMIS (NCT03803007) is a multinational, multicenter, randomized, double-blind, placebo- controlled, single-parallel, escalating dose phase 1b/2a safety and efficacy study of glenzocimab used as an add-on to standard of care therapy for acute ischemic stroke.

“We are proud to have completed patient recruitment for phase 1b/2a of the ACTIMIS study in Acute Ischemic Stroke with glenzocimab. This is a novel first-in-class treatment in this indication, which inhibits GPVI without increasing the risk of bleeding, and thus a source of new perspectives in the field. The development of several other drug candidates has failed in recent years, mainly due to safety concerns that included excessive bleeding risks. We are particularly grateful to all the investigators who have coped with such fast-paced recruitment despite the current COVID-19 pandemic. We would also like to seize this opportunity to applaud all healthcare providers who have stepped up during the pandemic to serve their patients.” says Prof. Mikael Mazighi, M.D., Ph.D., Coordinating Investigator for ACTIMIS.

In September 2020, Acticor Biotech had announced that the Target Dose of 1000mg in the first 60 patients of the study had been reached and this was confirmed by the Drug Safety Monitoring Board (DSMB).

The primary objective of this additional 100-patient group randomized to either 1000mg glenzocimab or its matching placebo was to evaluate the safety of glenzocimab as an add-on to thrombolysis alone or thrombolysis plus thrombectomy.

Six countries (France, Spain, Belgium, Germany, Switzerland and Italy) have actively participated in including a total of 166 patients for the ACTIMIS trial. No safety issues have so far been detected by the Drug Safety Monitoring Board (DSMB) at any point during this study.


Original website Link: