ACTICOR adapts its ACTISAVE clinical study to prepare the registration of glenzocimab for the treatment of stroke
- Clinical results from ACTISAVE phase 2/3 study now expected in the second quarter of 2024
- Optimised development plan to register glenzocimab in Europe and the United States projected no later than 2028
Paris, France, September 14, 2023 - 5.45 pm CEST - Acticor Biotech, (ISIN: FR0014005OJ5 - ALACT), a clinical stage biopharmaceutical company developing glenzocimab, an innovative drug for the treatment of cardiovascular emergencies, announced today its optimised development plan for Acute Ischemic Stroke (AIS) to register glenzocimab in Europe and the United States.
ACTISAVE (NCT05070260) is an international phase 2/3 study, adaptive, multicentre, randomised, double-blind, placebo-controlled, parallel-group evaluating the safety and efficacy of a single dose of glenzocimab used in combination with the reference treatment (thrombolysis with or without mechanical thrombectomy) for acute ischaemic stroke.
After consultation with the European (EMA) and US (FDA) regulatory agencies, in agreement with ACTISAVE's scientific committee, Acticor Biotech has decided to change the dual primary endpoint of this study to a single endpoint, namely the reduction in the number of patients who died or suffered from severe disability as a result of the stroke (mRS score 4-6 at 90 days). This modification of the primary endpoint, reducing the size of the study to 400 patients compared to 1,000 initially planned, will enable clinical results to be obtained as early as in the second quarter of 2024.
Amending ACTISAVE study protocol should enable:
- a quicker confirmation of the efficacy and safety results obtained in February 2022 in the ACTIMIS
study (and recently confirmed by the Brainomix study);
- a simplification of the evaluation, replacing the interim futility analyses planned by a final analysis;
- an opportunity to evaluate additional endpoints and several subpopulations, optimally supporting
the best possible design and making it possible to identify those patients who should draw the best benefit from glenzocimab.
To date, the ACTISAVE study deployed in the United States, Europe, Israel, and the United Kingdom, has recruited more than 380 patients, 35% of whom have undergone a mechanical thrombectomy. Comparison of the patient populations included in ACTISAVE and ACTIMIS studies suggests that ACTISAVE patients will be more representative, in terms of severity at inclusion, of the general population of patients treated in hospital for a stroke.
Regarding the pharmaceutical development plan, Acticor received the opinion from EMA and FDA during the summer. The authorities confirmed the relevance of the registration strategy in terms of production process validation and glenzocimab characterization. Recommendations have been proposed and will be implemented in the roadmap, without impacting the registration plan.
Based on the results of the ACTISAVE phase 2/3 study and on recommendations from world leading stroke experts, Acticor plans to consult the EMA and FDA again during 2024 to confirm that the phase 3 design will support registration in both Europe and the United States, projected no later than 2028.
Gilles Avenard, Chief Executive Officer of Acticor Biotech, commented: "We are very pleased with this strategic decision, which will enable us to obtain clinical results as early as mid-2024. We will then have two independent studies showing the efficacy of our drug and we will be able to define, in consultation with the FDA and the EMA, the design of phase 3 for the registration of this promising drug in the treatment of the acute phase of stroke. This evolution of our clinical strategy also has the advantage of reducing our current costs and consequently our financing requirements for 2024”