Acticor Biotech Receives European Medicines Agency (EMA) Endorsement on Key Parameters of ACTISAVE, Its Pivotal Phase II/III Study for Registration in Stroke

Regulatory News:

Acticor Biotech, (ISIN: FR0014005OJ5 - ALACT) (Paris:ALACT), 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.

As reminder, the positive results of the ACTIMIS phase 1b/2a clinical trial evaluating glenzocimab in combination with the reference treatment (thrombolysis with or without thrombectomy) in patients presenting with acute ischemic stroke (AIS) demonstrated glenzocimab very favorable safety profile by meeting the main criterion of the trial as well as by showing a significant reduction in the number of intracerebral hemorrhages and mortality in the group treated with glenzocimab.

Glenzocimab was granted PRIME designation in July 2022, and frequent interactions with the EMA will be planned under the PRIME scheme to optimize the development plan and facilitate quicker access for patients of the drug candidate. To date, the ACTISAVE study has enrolled more than 180 patients. A first futility analysis is planned after 200-300 patients will have been recruited, treated, and monitored for 90 days to confirm safety and ascertain that preliminary results are aligned with the initial trial assumptions.