Acticor Biotech Announces FDA Acceptance of IND Application for Glenzocimab in Acute Ischemic Stroke

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PARIS–(COMMERCIAL THREAD) – Regulatory news:

ACTICOR BIOTECH (ISIN: FR0014005OJ5 – ALACT), a clinical-stage biotechnology company involved in the acute phase of thrombotic diseases, today announces that the United States Food and Drug Administration (FDA) has authorized the launch of a clinical trial in the United States with glenzocimab, a new humanized monoclonal antibody fragment for use in patients with acute ischemic stroke.

This active IND represents an important milestone and marks the launch in the United States of the Phase 2/3 clinical trial with glenzocimab in acute ischemic stroke as an adjunct to standard therapy for this indication.

“The development of new therapeutic options for the treatment of the acute phase of ischemic stroke without increasing the risk of bleeding is a major medical need for years to come. The acceptance by the FDA of an IND application for glenzocimab and the clinical program to be carried out by Acticor Biotech in the United States are important steps in providing new, safe treatments for stroke patients ”, says Prof. James Grotta, MD, Memorial Hermann Hospital, Texas Medical Center, global coordinating researcher for ACTISAVE.

“We are very happy to have reached this milestone, which materializes our clinical objective stated during our IPO which took place a few days ago, to register a first American patient in the first quarter of 2022, following the registration of a first patient in Europe. end of September 2021 “, concluded Gilles Avenard, CEO of Acticor Biotech.

ACTISAVE (NCT05070260) is a multinational, randomized, double-blind, multicenter, placebo-controlled, parallel-group, single-dose, phase 2/3 adaptive efficacy and safety study in which patients are randomized to receive 1,000 mg of glenzocimab or its corresponding placebo. Its primary objective is to assess the effectiveness of glenzocimab in addition to standard care, thrombolysis alone or thrombolysis plus thrombectomy, with particular emphasis on the modified Rankin score at day 90 (mRS), for acute ischemic stroke.

Launched at the end of September 2021 in Europe, ACTISAVE follows the end of the recruitment of the ACTIMIS study, a phase 1b / 2a study of dose escalation and tolerance in 160 patients (NCT03803007), which made it possible to select the dose recommended dose of 1000 mg and confirmation of the favorable safety profile of glenzocimab (full results are expected by the first quarter of 2022). Eight countries are expected to be involved with a total of 1000 patients. A first futility analysis is planned after the enrollment of 200 patients.

About glenzocimab (ACT017), the therapeutic candidate

Acticor Biotech is developing glenzocimab (ACT017), a fragment of humanized monoclonal antibody (Fab). This therapeutic candidate is directed against a new target of major interest, platelet glycoprotein VI (GPVI), and inhibits its action. Evidence for the antithrombotic efficacy of glenzocimab and the safety of its inhibition of GPVI has been established both ex vivo and in vivo. This target is involved in the growth of the thrombus but not in the physiological haemostasis, which thus limits the haemorrhagic risk linked to its inhibition.

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About glenzocimab and COVID-19

Glenzocimab is also being evaluated as a treatment for acute respiratory distress syndrome (ARDS) in patients infected with COVID-19 (SARS-Cov-2) to contain the contribution of platelets to uncontrolled lung inflammation and thus prevent complications in downstream due to the pro-thrombotic. conditions without causing bleeding. The primary objective of the GARDEN study (NCT04659109) is to assess the effect of glenzocimab in preventing clinical disease progression when added to standard care in COVID-19 patients with ARDS. In July 2021, the 60 patients for the study were recruited and full results are expected by the first quarter of 2022.

About ACTICOR BIOTECH

Acticor Biotech is a clinical stage biopharmaceutical company, a spin-off from INSERM (National Institute for Health and Medical Research), which is developing an innovative treatment for acute thrombotic diseases, including ischemic stroke.

At the end of October 2021, Acticor biotech received the Galien Medstartup Award in the category “best collaboration in the pharmaceutical or biotechnology industry” for its collaboration with Prof. James Grotta at Memorial Hermann Hospital, TX.

Acticor Biotech is supported by a panel of European and international investors (Karista, Go Capital, Newton Biocapital, CMS Medical Venture Investment (HK) Limited, A&B (HK) Limited, Mirae Asset Capital, Anaxago, Primer Capital, Mediolanum farmaceutici and l ‘Armesa foundation). Acticor Biotech has been listed on Euronext Growth since November 2021 (ISIN: FR0014005OJ5 – ALACT).

For more information, visit www.acticor-biotech.com

Forward-looking statements

Certain information contained in this press release are not historical facts but are forward-looking statements. These forward-looking statements are based on current beliefs, expectations and assumptions, including, without limitation, assumptions regarding the current and future strategy of Acticor Biotech and the environment in which Acticor Biotech operates, and involve risks, uncertainties and other known and unknown factors, which may cause actual results, performance or achievements, or industry results or other events, to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include those set out and detailed in Chapter 3 “Risk factors” of Acticor Biotech’s reference document which was approved by the Financial Markets Authority on September 27, 2021 under number I.21-054.

Forward-looking statements speak only as of the date of this press release and Acticor Biotech expressly disclaims any obligation or commitment to publish any update or revision to any forward-looking statement included in this press release to reflect any change in expectations. or any change in the events, conditions or circumstances on which these forward-looking statements are based. Forward-looking information and statements are not guarantees of future performance and are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Acticor Biotech. Actual results could differ materially from those expressed, implied or projected by forward-looking information and statements.

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