ACTIMIS Post-hoc Results on Imaging Stroke Data Using Artificial Intelligence Reinforces Glenzocimab Mode of Action in Stroke Patients

PARIS–(BUSINESS WIRE)–Acticor Biotech, (ISIN: FR0014005OJ5 – ALACT), a clinical stage biopharmaceutical company developing glenzocimab, an innovative drug for the treatment of cardiovascular emergencies, announced today the results of its collaboration with Brainomix Limited, to further explore the imaging data using Artificial Intelligence (AI) from its phase 1b/2a ACTIMIS study.

The ACTIMIS clinical trial evaluating glenzocimab in combination with the reference treatment (thrombolysis with or without thrombectomy) in patients presenting with Acute Ischemic Stroke (AIS) has demonstrated a favorable safety profile of glenzocimab, as well as a significant reduction in the number of intracerebral hemorrhages and mortality in the group treated with glenzocimab.

To explore the mode of action of glenzocimab in the reduction of intracranial hemorrhage occurrence, a collaboration has been setup with Brainomix, a UK company specialized in the creation of AI-powered imaging biomarkers, to further analyze imaging stroke results from ACTIMIS study.

In a post-hoc analysis of the ACTIMIS study results, ischemic injury and hemorrhagic transformation volume measurements were quantified using AI-enabled Brainomix software. This provided an objective assessment of the evolution of the stroke brain injury which was associated with clinical outcome. First results using these biomarkers showed that patients treated with glenzocimab had smaller stroke lesion volumes compared to placebo-recipients (standard of care only), mainly due to a significant reduction in hemorrhagic transformation volumes. The benefit of glenzocimab was more pronounced in patients having undergone a mechanical thrombectomy after an initial treatment by a thrombolytic agent.

Yannick PLETAN, Chief Medical Officer and General Manager of Acticor Biotech, explained: “We are delighted with this collaboration with Brainomix, which enables us for the first time to analyze in greater detail the brain images of patients in the ACTIMIS study. Preliminary results seem to show that glenzocimab not only reduces the occurrence of intracranial hemorrhages, but also their volume, compared with placebo. These results support the first analyses of the ACTIMIS study and will be submitted for publication at upcoming international congresses.”

George HARSTON, Chief Medical Officer of Brainomix and Consultant Stroke Physician said: “We are excited to have partnered with Acticor Biotech to support this innovative analysis of the ACTIMIS study using our AI-powered imaging biomarkers. The Brainomix core lab analysis has helped elucidate the mechanism and demonstrate efficacy of glenzocimab. It has shown that glenzocimab reduced brain injury following thrombolysis in stroke, and identified subgroups of patients who appear to benefit most.”

About BRAINOMIX Limited

Brainomix specializes in the creation of AI-powered software solutions to enable precision medicine for better treatment decisions in stroke, lung fibrosis, and cancer. With origins as a spin-out from the University of Oxford, Brainomix is an expanding commercial-stage company that has innovated award-winning imaging biomarkers and software solutions that are used in more than 30 countries worldwide and in multiple clinical trials for patient selection and AI core lab analysis. Its first product, the Brainomix 360 platform, provides clinicians with the most comprehensive stroke imaging solution, driving faster treatment times and improving functional independence for patients.

About ACTICOR BIOTECH

Acticor Biotech is a clinical stage biopharmaceutical company, a spin-off from INSERM (the French National Institute of Health and Medical Research), which is aiming to develop an innovative treatment for cardiovascular emergencies, including ischemic stroke.

The positive results from its Phase 1b/2a study, ACTIMIS, confirmed the safety profile and showed a reduction in mortality and intracerebral hemorrhage in the glenzocimab-treated group in patients with stroke. The efficacy of glenzocimab is now being evaluated in an international Phase 2/3 study, ACTISAVE, which will include 1,000 patients. In July 2022, Acticor Biotech was granted “PRIME” status by the European Medicines Agency (EMA) for glenzocimab in the treatment of stroke. This designation will allow the company to strengthen its interactions and obtain early dialogues with regulatory authorities.

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

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

Disclaimer

This press release contains certain forward-looking statements concerning Acticor Biotech and its business. Such forward-looking statements are based on assumptions that Acticor Biotech considers to be reasonable. However, there can be no assurance that such forward-looking statements will be verified, which statements are subject to numerous risks, including the risks set forth in the Document de référence registration document as approved by the Autorité des marchés financiers under number R. 22-011 on 26 April 2022 and to the development of economic conditions, financial markets and the markets in which Acticor Biotech operates. The forward-looking statements contained in this press release are also subject to risks not yet known to Acticor Biotech or not currently considered material by Acticor Biotech. The occurrence of all or part of such risks could cause actual results, financial conditions, performance or achievements of Acticor Biotech to be materially different from such forward-looking statements.