Acticor Biotech obtains "PRIME" status from the European Medicines Agency for glenzocimab in the treatment of stroke
* Strengthening discussions with regulatory authorities to accelerate the clinical development of glenzocimab for its potential benefit in the treatment of stroke
* 87 patients already enrolled in Europe in the ACTISAVE Phase 2/3 registration study in stroke patients
Paris, France, July 21, 2022 - 7:00 PM CEST - ACTICOR BIOTECH (ISIN: FR0014005OJ5 - ALACT), a clinical-stage biotechnology company developing innovative drugs for the treatment of cardiovascular emergencies, in particular stroke, announced today that it has received "PRIority Medicines" status from the European Medicines Agency (EMA) for its drug candidate, glenzocimab, for the treatment of patients with stroke.
The "PRIME" status granted by the European Medicines Agency (EMA) allows to reinforce the support for the development of drugs that target an unmet medical need. This status will allow Acticor Biotech to strengthen interactions and obtain early dialogues with regulatory authorities in order to confirm the clinical development plan for glenzocimab in the treatment of stroke.
Glenzocimab is currently being evaluated in the Phase 2/3 registration ACTISAVE study in stroke patients. This study started in Q3 2021, with the inclusion of the first patient in Europe. In parallel, ACTICOR had obtained an IND for this study from the U.S. Food and Drug Administration (FDA) in November 2021. To date, 87 patients have already been enrolled in Europe.
A total of 1,000 patients will be included in the United States and Europe. An interim futility analysis is planned after inclusion of the first 200 patients to confirm the baseline hypotheses.
Yannick Pletan, General Manager & CMO of Acticor Biotech, said: "We are delighted that the European Medicines Agency has granted "PRIME" status to glenzocimab. This designation is both a recognition of the significant unmet medical need for stroke and a validation of the relevance of the positive clinical results of our Phase 1b/2a ACTIMIS study with glenzocimab in stroke patients. We will now be able to more easily pursue our discussions with regulatory authorities and ensure the smooth continuation of the ACTISAVE Phase 2/3 clinical trial, conducted in the United States and in Europe. To date, 87 patients have already been enrolled across Europe, which is perfectly in line with our theoretical inclusion curve. The good recruitment momentum in this study will lead, as previously announced, to the interim futility analysis, scheduled after the inclusion of the 200 patients, in the first half of 2023."