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. The proposed administration regimen for glenzocimab is a 6-hour intravenous infusion to cover the duration of the acute phase, being initiated within 0 to 4.5 hours from the onset of stroke symptoms.

AS AN ADD-ON THERAPY TO STANDARD OF CARE

ACTIMIS Study

Acticor Biotech is conducting a phase 1b/2a clinical trial to evaluate glenzocimab 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. By the end of June 2021, all patients have been enrolled in the study, and the primary results are expected in the first quarter of 2022.

AS AN ADD-ON THERAPY TO THROMBOLYSIS

Actisave study

Acticor Biotech is launching 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 will be to evaluate the efficacy of glenzocimab administred within the first 4.5 hours of symptom onset. A total of 1000 patients will be enrolled in this study, the first patient being included by the end of 2021. A futility analysis is planned after the first 200 patients and a second interim analysis after the first 400 patients.

AS ADJUNCTIVE THERAPY TO MECHANICAL THROMBECTOMY

GREEN study

Acticor Biotech is also partner in the RHU BOOSTER consortium, dedicated to the management of and new treatments for cerebrovascular accidents in emergency situations. In collaboration with Paris Public Hospitals (AP-HP), another clinical trial focusing on thrombectomy (GREEN) is also planned to start by the end of 20211. The primary objective of GREEN will to be to evaluate the efficacy of glenzocimab used as adjunctive therapy to mechanical thrombectomy.

Sources

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