ニュース
Presentation of the main results of the phase 2/3 ACTISAVE study in the treatment of stroke at ESOC 2024
• Data on specific subgroups pave the way for new perspectives
• Continued commitment to conduct the phase 2/3 GREEN and phase 2b
Paris, France, May 15, 2024 – 11:15 am CEST - ACTICOR BIOTECH (ISIN: FR0014005OJ5 – 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 10th 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 15th, 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.