BOOSTER is financially supported by the French National Research Agency (ANR) and the Government’s Investments for the Future program (PIA)
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.
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 Biotecth 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
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.
Acticor Biotech is also partner in the RHU BOOSTER consortium, dedicated to the management of and new treatments for cerebrovascular accidents in emergency situations1.
In this context, Acticor Biotech is participating in 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).
 BOOSTER is financially supported by the French National Research Agency (ANR) and the Government’s Investments for the Future program (PIA)