Acticor Biotech obtains “PRIME” status from the European Medicines Agency for glenzocimab in the treatment of stroke – 07/21/2022 at 19:00


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• Strengthened discussions with regulatory authorities to accelerate the clinical development of glenzocimab for its potential benefit in the treatment of stroke

• 87 patients already recruited in Europe in the ACTISAVE phase 2/3 registration study conducted in patients with stroke

Yannick Pletan, Acticor Biotech’s Deputy CEO said: “We are delighted that the European Medicines Agency has granted glenzocimab PRIME status. This designation is both an acknowledgment of the significant unmet medical need represented by stroke, but also a validation of the relevance of the positive clinical results of our phase 1b/2a ACTIMIS study conducted with glenzocimab in patients with Stroke. We will now more easily pursue our discussions with the regulatory authorities and ensure the good continuity of the ACTISAVE phase 2/3 clinical study, conducted in the United States and Europe. To date, 87 patients have already been recruited across Europe, which is perfectly in line with our theoretical inclusion curve. The good momentum of recruitment in this study will lead, in accordance with what we had announced, to the interim analysis of futility, planned after the inclusion of the 200th patient, in the 1st half of 2023.”



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