A biotech company developing drugs for cardiovascular emergencies, specifically strokes, has received priority medicines status from the European Medicines Agency (EMA) for its drug candidate, glenzocimab.
Paris-based Acticor Biotech made the announcement yesterday (July 21) and the prime status allows reinforcement of support for the development of drugs that target an unmet medical need. It will also allow the company to strengthen interactions and get early dialogues with regulatory authorities to confirm the clinical development plan for glenzocimab in the treatment of strokes.
Glenzocimab is currently being evaluated in the phase 2/3 registration ACTISAVE study in stroke patients. This study started in the third quarter of last year (2021), with the inclusion of the first patient in Europe.
At the same time, Acticor had obtained an Investigational New Drug (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 U.S. and Europe. An interim futility analysis is planned after inclusion of the first 200 patients to confirm the baseline hypotheses.
Yannick Pletan, general manager 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.”
In June this year (2022) Acticor announced the European Patent Office (EPO) had granted a new patent that provides protection for the use of glenzocimab in thrombotic diseases in Europe until 2036.