Acticor Biotech, today announced the enrollment of the first patient in the USA in its Phase 2/3 registration study ACTISAVE, which is evaluating glenzocimab in patients with acute ischemic stroke.
This first US patient was enrolled at the CHI Memorial Stroke and Neuroscience Center, Chattanooga, Tennessee, by Dr. Ruchir A. Shah, MD, Neurologist who said: “I am very happy with this first patient inclusion in the United States in ACTISAVE study. Glenzocimab has significant potential for improvement in patients with ischemic stroke, especially those undergoing mechanical thrombectomy. We urgently need new drugs in this indication, and glenzocimab presents an innovative and promising mechanism of action on recanalization and on the downstream microcirculation
ACTICOR had obtained an IND for this study from the U.S. Food and Drug Administration (FDA) in November 2021 and had initiated enrollment in Europe in the third quarter of 2021. To date, the study has enrolled 130 patients.
The clinical trial is planned for 1,000 patients treated at approximately 80 centers in the USA, Europe (France, Germany, Belgium, Spain, Slovakia, Denmark, Czech Republic), Great Britain and Israel. A first futility analysis is planned after the inclusion of the first 200 patients to confirm the initial hypotheses.
Dr. Yannick PLETAN, Chief Operating Officer, and Chief Medical Officer of Acticor Biotech added: “The opening of the first U.S. centers, in addition to those already active in Europe, marks another important milestone for our ACTISAVE Phase 2/3 study. The cumulative incidence of ischemic stroke in the USA, Europe, Japan, and China will approach 4 million patients by 2026 , highlighting the urgent need for an effective treatment to address this major public health problem with a strong societal and economic impact.”
In July 2022, Acticor Biotech was granted Priority Medicines (PRIME) status by the European Medicines Agency for glenzocimab in the treatment of stroke, recognizing the potential clinical benefit of glenzocimab and its relevance to the unmet medical need in this disease. Because efficacy data were a secondary endpoint of the Phase 1b/2a ACTIMIS study, glenzocimab was not eligible for Breakthrough Therapy status despite significant data on mortality and reduction of cerebral hemorrhage. Nevertheless, these data and the inclusion of patients in the USA will allow Acticor Biotech to apply for Fast Track status with the FDA in the coming weeks.
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