ACTICOR BIOTECH

Topline Results of ACTISAVE Phase 2/3 Study in Stroke Treatment

Regulatory News:

ACTICOR BIOTECH (FR0014005OJ5 - ALACT) (Paris:ALACT), a clinical-stage biotechnology company focused on the development of glenzocimab, an innovative drug for the treatment of cardiovascular emergencies, today announced the first results of its ACTISAVE phase 2/3 study in the treatment of acute ischemic stroke.

Analysis of the first results shows no evidence of efficacy for either the primary endpoint, the proportion of patients with severe disability or death (mRS 4-6) at 90 days after the stroke, or for the secondary endpoint, the proportion of patients with no disability (mRS 0-2) at 90 days.

As a reminder, ACTISAVE (NCT05070260), an international, adaptive, multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase 2/3 study, evaluated the safety and efficacy of a single dose of glenzocimab used in combination with the standard of care (thrombolysis +/- thrombectomy) for acute ischemic stroke. The study was deployed in the United States, Europe (8 countries), Israel and the United Kingdom.

Yannick PLETAN, General Manager & Chief Medical Officer, comments: "These results obtained with glenzocimab in combination with the reference stroke treatment are extremely disappointing and in contradiction with the results of the previous phase 1b/2a ACTIMIS study and pharmacological studies. The ACTISAVE study included 438 patients, of whom 421 were treated, including 211 in the glenzocimab arm. Treatment was systematically combined with thrombolysis, and for just over 30% of patients with mechanical thrombectomy. The study population proved to be significantly less severe than that of ACTIMIS, with a very high percentage of patients returning to near-normal life. This negative result for Acticor is also negative for the medical community awaiting new treatments. It contradicts the results of previous pharmacological studies and clinical data. Main quality aspects of the study were analysed and found to be compliant. ACTICOR is currently investigating any influencing factors that may have accounted for these results. We're also assessing the potential impact on the 2 other clinical studies currently underway: GREEN in stroke patients undergoing mechanical thrombectomy and LIBERATE in myocardial infarction (STEMI). We would like to thank all the patients who took part in the ACTISAVE study, as well as their doctors and hospital teams. The full data will be presented on May 15 at a plenary session of the European Stroke Organization Conference (ESOC) by Professor Martin Köhrmann, coordinating investigator."