Acticor Biotech, a clinical-stage biopharmaceutical company developing glenzocimab, an innovative drug for the treatment of cardiovascular emergencies, has discussed with the European Medicines Agency (EMA) the design of its pivotal Phase II/III study to support a potential future marketing authorization application (MAA) for its first-in-class drug, glenzocimab.
The discussion meeting took place remotely in October 2022, and Acticor Biotech provided a list of questions concerning the non-clinical development and the study design of the ACTISAVE study.
The final advice given by the Committee for Medicinal Product for Human use (CHMP) based on the questions and supporting discussion was very positive. The Agency endorsed the strategy of an adaptive design and validated the choice of two dual primary endpoints: the modified Rankin Scale as an ordinal scale in 7 categories from 0 to 6 and the binary endpoint defined as severe disability or death, i.e., mRS 4-6 (versus mRS 0-3).
Other key features of the study design were also endorsed, such as the two futility interim analyses proposed with their go/no go rules, the prespecified analysis in the promising subgroup of patients with thrombectomy and the adaptive reassessment of the sample size at the second futility analysis. Although CHMP recommendations were issued to further detail some analyses, the statistical methodology was therefore endorsed on its general principles.
In addition, the CHMP agreed that reproductive and developmental toxicity studies are not requested to support a future MAA, considering glenzocimab profile and safety results on previous nonclinical studies.
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