Acticor Biotech SAS

Results from a phase 2b trial in myocardial infarction are expected at the end of next year. Acticor Biotech is discontinuing a phase 2/3 study of a blood thinner given alongside heart surgery based on the results of a futility analysis.The French company had been testing the drug, glenzocimab, as an adjunct to mechanical thrombectomy in patients who have suffered an acute ischemic stroke. More than 100 patients have been enrolled in the study to date, with the futility analysis conducted on data from the first 78 participants.“In the light of the information provided to the members of the Independent Monitoring Committee (IMC), and in accordance with the futility criteria defined in the protocol, the IMC recommends that the GREEN study be discontinued,” Acticor said in a Friday release.Glenzocimab, which is Acticor’s sole asset, is an antibody fragment that’s directed against platelet glycoprotein VI (GPVI). The protein is critical for blood clot formation but doesn’t affect the regulation of bleeding, making it an ideal target for safely inhibiting platelet clumps.Glenzocimab is undergoing or in line for a number of clinical trials in relation to strokes or heart attacks, but this isn’t the first time the drug has come up short. In April, glenzocimab failed to hit the primary endpoint of reducing the risk of severe disability or death in the wake of a stroke across a separate phase 2/3 study. Early hopes for glenzocimab were that it could cut the risk of uncontrolled bleeding that can be a side effect of widely prescribed blood thinners such as COX-1 inhibitor aspirin and P2Y12 antagonist Plavix. This theory was back up by a small first-in-human study of the drug in healthy volunteers that read out in 2019.Those hopes continued into January 2024, when a phase 1b/2a study showed a reduction in mortality and brain bleeding among stroke patients who received the drug.Results from a phase 2b trial in myocardial infarction, a term for a heart attack, are expected at the end of next year.

With these latest studies, the firmly established European market leader in stroke AI imaging adds to its growing body of evidence. The latest research reflects the company's extensive academic collaborations and its growing Life Science partnerships. OXFORD, England and CHICAGO, May 16, 2024 /PRNewswire/ -- Brainomix, a pioneer in artificial intelligence (AI) imaging solutions to enable precision medicine, announced a series of new studies that were presented this week at the European Stroke Organisation Conference (ESOC) in Basel. The studies validated the impact of the Oxford-based company's Brainomix 360 Stroke platform, including its FDA-cleared Triage Stroke tool and its flagship e-ASPECTS software. The studies follow Wednesday's presentation at ESOC of a groundbreaking study, the largest prospective evaluation of stroke AI imaging, involving more than 80,000 patients at 26 sites over a 3-year period. This study showed that the implementation of Brainomix 360 Stroke was associated with an additional 50% increase in the number of patients receiving mechanical thrombectomy and a reduction in door-in-door-out (DIDO) time of around 50 minutes. Dr Michalis Papadakis, CEO and Co-Founder of Brainomix, said: "The studies presented this week at ESOC reflect our ongoing commitment to scientific excellence and our extensive academic collaborations with world-class research institutions, including the Mayo Clinic, the Rockefeller Institute at West Virginia University, and Boston Medical Center. These studies provide further validation that our AI-enabled technology can play a critical role in stroke care, helping clinicians make more confident decisions leading to more patients getting access to life-saving treatments. "We are also proud to showcase the growing body of research we are conducting with Life Science partners. Our unique set of imaging biomarkers and clinical trial tools, along with our world-class core lab team, are delivering real value for pharma partners, device manufacturers and biotech companies, generating insights that may guide future clinical trial design." Key abstracts accepted and presented at ESOC included: "Large Vessel Occlusion Detection in Acute Ischemic Stroke Using Non-Contrast CT" was a multisite collaboration with the Mayo Clinic, the Rockefeller Neuroscience Institute at West Virginia University, and Boston Medical Center validating Triage Stroke as a reliable tool for large vessel occlusion (LVO) detection. The authors concluded that when coupled with clinical information such as NIHSS, the tool may help centers to identify thrombectomy candidates, especially those with constrained resources and basic imaging. Brainomix and CSL Behring jointly published a retrospective observational study, "Automatically Quantified Follow-Up Imaging Biomarkers as Predictors of Clinical Outcomes after Acute Ischemic Stroke: A Real-World Evidence Study." After processing NCCT follow-up images with Brainomix 360 Stroke software, the results validated the prognostic significance of automated final infarct volume (FIV) and its components, confirming the opportunity for AI-derived imaging biomarkers at follow-up time points to improve the design and delivery of randomized controlled trials in AIS. Brainomix and Acticor jointly published a poster, "Patients Randomized to Glenzocimab Suffered Less Hemorrhagic Transformation with Greater Benefit in Larger Baseline Infarct Core," which helped to elucidate the mechanism and demonstrate the efficacy of Acticor's drug, glenzocimab, while identifying subgroups of patients who appear to benefit the most. A UK study, "WOW (With Or Without): Measuring Impact of e-ASPECTS Software on Conventional CT Reporting in Acute Ischemic Stroke," validated the impact of e-ASPECTS on reader performance. "e-ASPECTS is a valuable tool for clinicians in the speedy and accurate diagnosis of acute ischemic stroke (AIS), and has the potential to enable the identification of AIS patients in centres without neuroradiology expertise, improving access to life-saving treatment," noted Dr Anna Podlasek, lead author of the study. RESILIENT Extend IV, an ongoing randomized controlled trial assessing Tenecteplase in non-LVO AIS patients in the extended time window, will provide an update on its progress. The Brazilian trial is using Brainomix 360 e-CTP for patient selection. About Brainomix Brainomix specializes in the creation of AI-powered software solutions to enable precision medicine for better treatment decisions in stroke and lung fibrosis. With origins as a spin-out from the University of Oxford, Brainomix is an expanding commercial-stage company with offices in the UK, Ireland and the USA, and operations in more than 30 countries. A private company, backed by leading healthtech investors, Brainomix has innovated award-winning imaging biomarkers and software solutions that have been clinically adopted in hundreds of hospitals worldwide. Its first product, the Brainomix 360 stroke platform, provides clinicians with the most comprehensive stroke imaging solution, driving increased treatment rates and improving functional independence for patients. To learn more about Brainomix and its technology visit , and follow us on Twitter, LinkedIn and Facebook. Contacts Jeff Wyrtzen, Chief Marketing & Business Development Officer [email protected] M +44 (0)7927 164210 T +44 (0)1865 582730 Media enquiries Charles Consultants Sue Charles [email protected] M +44 (0)7968 726585 Logo - SOURCE Brainomix

PARIS--(BUSINESS WIRE)-- September 7th, 2023, the University of Birmingham and Acticor Biotech (Paris:ALACT) announce the full regulatory approval of LIBERATE clinical study. In 2021, the University of Birmingham and Acticor Biotech signed a partnership agreement to evaluate glenzocimab efficacy in myocardial infarction in a new clinical trial called LIBERATE. The University has received full regulatory approvals to initiate the study. This new clinical trial is based on a long-standing collaboration between Acticor Biotech and the University of Birmingham. The publication in August of a scientific paper from Dr Mark Thomas entitled: “Amplified inhibition of atherosclerotic plaque-induced platelet activation by glenzocimab with dual antiplatelet therapy “ (link to the publication) in the Journal of Thrombosis and Haemostasis, reinforced the mode of action of glenzocimab and its major role as an antithrombotic drug. The randomised, double-blind Phase 2b LIBERATE study will recruit more than 200 patients suffering from a ST-elevation myocardial infarction (STEMI) and planned for a percutaneous coronary intervention. The study aims to assess the safety and the efficacy of glenzocimab 1000 mg versus placebo to reduce the myocardial infarct size at Day 90 post-treatment. The trial will be conducted in two acute care hospitals in the UK: the Queen Elizabeth Hospital, Birmingham and the Northern General Hospital, Sheffield. Patient recruitment is expected to start by the end of 2023. Doctor Mark Thomas, Associate Professor of Cardiology at the University of Birmingham and Honorary Consultant Cardiologist, who designed the trial and led its development, said: “Our recent studies of glenzocimab at the University of Birmingham have just been published – these explain the cellular mechanisms for why it is highly effective at reducing “blood stickiness”, particularly when combined with existing medications. We are very pleased to receive regulatory approval to launch the LIBERATE clinical trial to investigate whether glenzocimab can reduce the type of blood clotting that causes heart damage during heart attacks. This exciting collaboration with Acticor has the potential to benefit our patients in Birmingham and Sheffield, and across the world.” Professor Jon Townend, Consultant Cardiologist at University Hospitals Birmingham, Honorary Professor of Cardiology in the Institute of Cardiovascular Sciences at the University of Birmingham, and Chief Investigator of the trial said: “This new drug looks extremely promising and we are excited to be within sight of beginning recruitment for this important trial” Yannick Pletan, Chief Medical Officer, and General Manager of Acticor Biotech declared: “Glenzocimab has already delivered very promising results in the treatment of acute ischemic stroke and we hope to confirm its therapeutics potential in other cardiovascular emergency indications. LIBERATE phase 2b study extends glenzocimab development programme to myocardial infarction. We are delighted to collaborate with all the teams involved, the University of Birmingham particularly, sponsor of this study, to extend the therapeutic field of glenzocimab.” ENDS Notes to editor: The University of Birmingham is ranked amongst the world’s top 100 institutions. Its work brings people from across the world to Birmingham, including researchers, teachers and more than 6,500 international students from over 150 countries. The University of Birmingham is a member of Birmingham Health Partners (BHP), a strategic alliance which transcends organisational boundaries to rapidly translate healthcare research findings into new diagnostics, drugs and devices for patients. Birmingham Health Partners is a strategic alliance between five organisations who collaborate to bring healthcare innovations through to clinical application: University of Birmingham University Hospitals Birmingham NHS Foundation Trust Birmingham Women's and Children's Hospitals NHS Foundation Trust Sandwell and West Birmingham Hospitals NHS Trust West Midlands Academic Health Science Network 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. Acticor Biotech is developing glenzocimab (ACT017), a humanized monoclonal antibody (mAb) fragment directed against a novel target of major interest, platelet glycoprotein VI (GPVI). Glenzocimab inhibits platelet binding to the thrombus without affecting physiological hemostasis, thereby limiting the bleeding risk, particularly in the brain. The positive results from its Phase 1b/2a study, ACTIMIS, confirmed the safety pro 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 ACTISAVE, an international Phase 2/3 study. 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 (Karista, Go Capital, Newton Biocapital, CMS Medical Venture Investment (HK) Limited, A&B (HK) Limited, Mirae Asset Capital, Anaxago, Primer Capital, Mediolanum farmaceutici and the Armesa foundation). Acticor Biotech is listed on Euronext Growth Paris since November 2021 (ISIN: FR0014005OJ5 – ALACT). For more information, visit: 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.