ACTICOR BIOTECH: Presentation of the Main Results of the Phase 2/3 ACTISAVE Study in the Treatment of Stroke at ESOC 2024

PARIS–(BUSINESS WIRE)–Regulatory News:

“ACTISAVE Clinical Trial: Efficacy and Safety of Glenzocimab on Top of Thrombolysis with or without Mechanical Thrombectomy.”

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ACTICOR BIOTECH (ISIN: FR0014005OJ5 – ALACT) (Paris:ALACT), a clinical stage biopharmaceutical company developing glenzocimab, an innovative drug for the treatment of cardiovascular emergencies, including stroke, announces the presentation, on Wednesday, May 15, 2024 during the opening session of the 10^th European Stroke Organisation Conference (ESOC), of the phase 2/3 study results, ACTISAVE, in the treatment of acute ischemic stroke.

On this occasion, Professor Martin Köhrmann, M.D., PhD., Coordinator Investigator of the ACTISAVE study, presented the main results of the study during the opening session of the conference “Official welcome & Large Clinical Trial“: “ACTISAVE Clinical Trial: Efficacy and Safety of Glenzocimab on Top of Thrombolysis with or without Mechanical Thrombectomy.” He also highlighted the differences between the ACTIMIS and ACTISAVE studies in terms of patient population.

Dr. Martin Köhrmann, M.D., PhD., Coordinator Investigator of the ACTISAVE study, stated: “The analysis of the phase 2/3 ACTISAVE study in the treatment of acute ischemic stroke did not demonstrate, in the overall population, the efficacy of glenzocimab on the primary endpoint, the proportion of patients with severe disability or death (mRS 4-6) 90 days after stroke, nor on the secondary endpoint, the proportion of patients returning to life without disability (mRS 0-2). However, a trend was observed in the proportion of patients returning to normal life (mRS 0-1), especially for patients with complete recanalization after thrombectomy (eTICI score 3). These data encourage us to search for patient subpopulations among whom an advantage of glenzocimab may be demonstrated, as its favorable safety profile remains confirmed in this study.”

Gilles Avenard, Chief Executive Officer, developed: “We are faced with results that challenge our initial expectations, but the further analysis of the study data on certain subgroups is promising. Glenzocimab has shown beneficial effects in certain patient subgroups that warrant further exploration, allowing us to consider continuing discussions with the pharmaceutical groups with whom we are in contact. These data encourage us to refine and potentially redefine the positioning of glenzocimab in the treatment of strokes.”

During this conference, in the “Hyperacute Management” session on Wednesday, May 15^th, Dr. Davide Carone from Brainomix Ltd will also present the latest brain imaging analyses obtained in the ACTIMIS study: “Patients randomized to Glenzocimab suffered less hemorrhagic transformation with greater benefit in larger baseline infarct core,” reinforcing the potential of glenzocimab in certain patient subpopulations, particularly those presenting larger volumes of cerebral infarction at baseline.

Glenzocimab is also being evaluated in two other clinical studies conducted by academic teams, which do not question their work and confirm their confidence in the potential of the product.

• Phase 2/3 GREEN study in the treatment of stroke in patients undergoing mechanical thrombectomy with a futility analysis after the inclusion of the first 78 patients (30% of patients) expected in the fourth quarter of 2024;

• Phase 2b LIBERATE study in the treatment of myocardial infarction with final results expected in the fourth quarter of 2025.

The company plans to actively continue discussions with pharmaceutical partners to explore potential strategic collaborations that could support future phases of glenzocimab’s development and clinical application.

As announced on April 25, 2024, during the release of the ACTISAVE results, the company is able to fund its operations until October 2024.

About ESOC

The European Stroke Organisation (ESO) is a pan-European society of researchers and physicians specializing in strokes, national and regional stroke societies, and non-professional organizations, founded in December 2007. ESO is a non-governmental organization composed of individual and organizational members. ESO serves as the voice of stroke in Europe, harmonizing stroke care across Europe and taking action to reduce the burden of stroke at regional and global levels.

The 10^th European Stroke Organisation Conference took place on May 15th, 16th, and 17th, 2024, in Basel.

About ACTICOR BIOTECH

Acticor Biotech is a clinical-stage biopharmaceutical company developing glenzocimab, an innovative drug for the treatment of cardiovascular emergencies, particularly ischemic stroke.

Positive results from the phase 1b/2a study, ACTIMIS, published in January 2024 in the Lancet Neurology (link to publication) confirmed the safety profile of glenzocimab and showed a reduction in mortality and intracerebral haemorrhage in the glenzocimab-treated group of stroke patients. A post-hoc analysis of brain imaging at 0 and 24 hours using artificial intelligence confirmed these results, showing a reduction in the number and volume of intracerebral lesions in patients treated with glenzocimab.

On April 25, 2024, the company announced the initial results of the ACTISAVE trial (NCT05070260), an international phase 2/3 study in the treatment of acute ischemic stroke, which showed no efficacy of glenzocimab on the primary endpoint, the proportion of patients with severe disability or death (mRS 4-6) 90 days after stroke, nor on the secondary endpoint, the proportion of patients returning to life without disability (mRS 0-2) 90 days after stroke.

ACTISAVE (NCT05070260), an international, adaptive, multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase 2/3 study, evaluated the safety and efficacy of a single dose of glenzocimab used in combination with the standard of care (thrombolysis +/- thrombectomy) for acute ischemic stroke. The study was deployed in the United States, Europe (8 countries), Israel and the United Kingdom.

Acticor Biotech is currently investigating any influencing factors that may have accounted for these results, which contradict the findings of pharmacology studies and previous clinical data.

Acticor Biotech is backed 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) and has been listed on Euronext Growth Paris since November 2021 (ISIN: FR0014005OJ5 – ALACT).

For further information, please visit: https://www.acticor-biotech.com/