(CercleFinance.com) – Acticor Biotech announced yesterday evening that it had decided to change the main criterion of its phase 2/3 study by retaining only one single criterion, namely the reduction in the number of patients who died or suffered from severe disability as a result of a stroke.
This change, which follows consultations with the European (EMA) and American (FDA) regulatory agencies, will make it possible to reduce the size of the study to 400 patients, compared to 1000 previously, and therefore make it possible to obtain clinical results. from mid-2024, and no longer in 2025.
In its press release, Acticor explains that the objective is to achieve registration of glenzocimab in Europe and the United States no later than 2028.
To date, the study deployed in the United States, Europe, Israel and Great Britain has recruited more than 380 patients, 35% of whom have undergone mechanical thrombectomy.
After jumping more than 5% mid-morning, Acticor shares listed on the Paris Stock Exchange were unchanged at lunchtime.