Acticor Biotech SAS announced Enrollment of more than 240 patients in the ACTISAVE Phase 2/3 study in stroke and regulatory progress with the EMA and FDA. ACTISAVE (NCT05070260), which will be launched in Europe in the third quarter of 2021, has so far enrolled more than 240 patients. As a reminder, this international Phase 2/3 study with glenzocimab in the acute phase of stroke is planning to recruit 1,000 patients in approximately 80 centers in the United States, European Union (France, Germany, Belgium, Spain, Slovakia, Denmark, Czech Republic), Great Britain and Israel.

From a regulatory perspective, the European Medicines Agency (EMA) approved the adaptive design strategy and validated the choice of a dual primary endpoint: an ordinal endpoint of the difference between the Modified Rankin Scale (mRS) groups3, and a binary endpoint of the percentage of patients with severe disability or death, i.e. mRS score 4-6. Recognition of the design of this pivotal study supports a future application for marketing authorization (MA) for glenzocimab in stroke in Europe. In the context of the "PRIME" status received in July 2022, a program recognizing unmet medical need and aimed at optimizing the development plan and speeding up access to the drug candidate for patients, the Company continues its interactions with the EMA. In the United States, written responses from the FDA in a Type C meeting are expected in May 2023 to validate the design and statistical analysis of the study, and to support a future application for marketing authorization, via a Biologic License Application (BLA) in the United States.

An amendment to the study protocol allowing the use of the two thrombolytic agents in stroke management, tenecteplase (TNK) and alteplase, was submitted to the FDA in November 2022, and approved by a Central Ethics Committee (IRB). First patients have been included to date and Acticor estimates that this amendment should accelerate patient enrollment in the study, given the massive use of TNK in U.S. hospitals. Initiation of patient enrollment in the GREEN Phase 2/3 study in stroke: Conducted under the auspices of the Assistance Publique - Hôpitaux de Paris, and part of the RHU BOOSTER, with the financial support of the Agence Nationale de la Recherche and the Programme Investissements d'Avenir, the GREEN study (NCT05559398) has started with the enrollment of the first patients at the beginning of 2023.

As a reminder, the primary objective of this study is to evaluate the efficacy of glenzocimab in combination with endovascular thrombectomy (EVT) versus EVT alone within the first 24 hours on the 90-day functional outcome (mRS). Secondary objectives are to evaluate the impact of glenzocimab on overall survival, reperfusion, clinical improvement at 24 hours, symptomatic and asymptomatic intracerebral hemorrhage, serious adverse events (SAEs), serious unexpected adverse events (SUSARs) and quality of life. This study will include nearly 260 patients eligible for mechanical thrombectomy in 11 French neurovascular units and institutions of excellence.

Discussions with the UK regulatory authorities for the LIBERATE study for the treatment of myocardial infarction. The LIBERATE study (IRAS -1005400), conducted in partnership with the University of Birmingham (UK), and expert clinicians from the Institute of Cardiovascular Sciencesand the University Hospitals Birmingham NHS Foundation Trust, iscurrently being submitted to the UK regulatory authorities (MHRA). This is a randomized, double-blind, phase 2b study that will include 212 patients in the acute phase of myocardial infarction to test the safety and efficacy of glenzocimab 1000 mg versus placebo on reducing cardiac damage remote from the infarction.