Glenzocimab
in acute ischemic stroke

An urgent need for new treatments

Unmet medical needs

Glenzocimab is being developed for use in the acute phase of ischemic stroke as an add-on therapy to thrombolysis with or without mechanical thrombectomy. In its letter granting the PRIME status to glenzocimab (link), the European Medicines Agency recognized the unmet medical need in ischemic stroke. Glenzocimab with a dual mode of action in the treatment of ischemic stroke, first at the primary occlusion site, but also in the micro-circulation to help the reperfusion of cerebral tissue can start to respond to this urgent need.

Source1

AS AN ADD-ON THERAPY TO STANDARD OF CARE

ACTIMIS Study

Glenzocimab has been evaluated in a phase 1b/2a clinical trial in Acute Ischemic Stroke as an add-on therapy to Standard of care (ACTIMIS NCT03803007).

Further to a first escalation-dose phase conducted in 60 patients to determine a safe dose, additional 100 patients have been recruited to either 1000mg glenzocimab or its matching placebo, to assess the safety of glenzocimab as an add-on to thrombolysis with or without thrombectomy.

In February 2022, Acticor Biotech announced positive results of the study:
- Achievement of the study’s primary endpoint, confirming glenzocimab’s very favorable safety profile
- Reduction in the number of intracerebral hemorrhages and mortality among patients treated with glenzocimab

ACTIMIS results were presented by Dr Mikael Mazighi, Coordinating Investigator of ACTIMIS Study, at the European Stroke Organization Conference 20222.

AS AN ADD-ON THERAPY TO STANDARD OF CARE

Actisave study

Acticor Biotech has launched in 2021 an international adaptive phase 2/3 clinical trial (ACTISAVE [NCT05070260]) to evaluate the efficacy and safety of glenzocimab as an add-on therapy to thrombolysis, with or without mechanical thrombectomy, in the acute phase of Ischemic Stroke. The primary objective of ACTISAVE was to evaluate the efficacy of glenzocimab administered within the first 4.5 hours of symptom onset.

The clinical trial was completed in January 2024, with 436 patients randomized in in over 50 centers in the USA, European Union (France, Germany, Belgium, Spain, Slovakia, Denmark, Czech Republic), United Kingdom and Israel. The study did not reach its primary endpoint on the reduction of poor outcomes. Further analysis of the data revealed a high patient heterogeneity at baseline and a trend in helping patients returning to normal life was observed. ACTISAVE results were presented by Prof. Martin Köhrmann at the European Stroke Organization Conference 2024. (Press release)

AS ADJUNCTIVE THERAPY TO MECHANICAL THROMBECTOMY

GREEN study

The RHU BOOSTER consortium is dedicated to the management of and new treatments for cerebrovascular accidents in emergency situations3.

In this context, Acticor Biotech is supporting a multicenter Phase 2/3 clinical trial including 260 stroke patients eligible for mechanical thrombectomy. The primary objective of this trial is to evaluate the efficacy of glenzocimab in combination with mechanical thrombectomy. The sponsor of this study is Assistance Publique des Hôpitaux de Paris (AP-HP).

RHU BOOSTER is supported by a government grant managed by the French National Research Agency (ANR) as part of the future investment program integrated into France 2030, under grant agreement No. ANR-18-RHUS-0001.

A futility analysis planned in the protocol of GREEN trial was performed on the first 78 patients. In the light of the information provided to the members of the Independent Monitoring Committee and in accordance with the futility criteria defined in the protocol, the sponsor Assistance Publique Hôpitaux de Paris (APHP) has decided to stop the GREEN study and halt enrolment.

Sources

[1] Sources: (1) Figure adapted from Campbell & al 2019. (2) Zinkstok & al Lancet 2012 (3) Bhaskar & al BMC Neurol 2018 (5) Jama & al AMA 2015 (6) Chia & al Stroke 2016 (7) Ng & al, Neurology 2022

[2] ESOC 2022 – Late breaking science, ongoing trials & young stroke physicians and researchers - Abstract #1758 - Glenzocimab, A Novel Antithrombotic, Is Associated With Reduced Intracranial Hemorrhage And Mortality Rates When Combined With Standard-Of-Care Reperfusion Therapies: The ACTIMIS Study. European Stroke Journal 2022; 7: 546–88.

[3] BOOSTER is financially supported by the French National Research Agency (ANR) and the Government’s Investments for the Future program (PIA)

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