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【Acticor Biotech-Product ACT017】Acticor Biotech has just and timely completed patient recruitment of its phase 2/3 study in stroke

Date:
2023-11-21
Category:
Partner News
  • ?438 patients with stroke have been randomized in ACTISAVE study evaluating glenzocimab, in the United-States, Europe, Israel and United Kingdom
  • Confirmation of clinical results communication for the second quarter 2024

Acticor Biotech (ISIN: FR0014005OJ5 – ALACT), a clinical stage biopharmaceutical company developing glenzocimab, an innovative drug for the treatment of cardiovascular emergencies, announced the timely completion of enrollment in the ACTISAVE Phase 2/3 clinical trial in patients with acute ischemic stroke (AIS) on November 7, 2023.

Gilles Avenard, General Manager of Acticor Biotech, declares: “We are pleased with the completion of the enrollment of our clinical study evaluating the efficacy of glenzocimab in 438 stroke patients exactly on schedule. We eagerly anticipate sharing the outcomes of this world-class study in the second quarter of 2024. This achievement bolsters our commitment to delivering an innovative drug for the treatment of cardiovascular emergencies, that is strengthened, moving forward at every milestone of development plan execution.”

ACTISAVE (NCT05070260) is an international, adaptive, multicenter, randomized, double-blind, placebocontrolled, parallel-group Phase 2/3 study evaluating the safety and efficacy of a single dose of glenzocimab used in combination with the standard of care (thrombolysis +/- thrombectomy) for acute ischemic stroke. Deployed in the United States, Europe, Israel, and United Kingdom, ACTISAVE has enrolled 438 patients, of whom about 40% have undergone mechanical thrombectomy.

As a reminder, following consultations with the European (EMA) and American (FDA) regulatory agencies, and in agreement with ACTISAVE Scientific Committee, Acticor Biotech decided in September 2023 to change the main endpoint of the study by retaining only one single endpoint, namely the reduction in the number of patients who died or suffered from severe disability as a result of AIS (mRS score 4-6 at 90 days). (mRS: modified Rankin scale)

As previously announced, phase 2/3 clinical results are expected in the second quarter of 2024.

Based on these results and the recommendations of international experts in stroke, Acticor Biotech plans to consult again with the EMA and the FDA in 2024 to confirm that the Phase 3 design will support final registration in both Europe and the United States, envisaged by 2028 at the latest.