- Achievement of ACTIMIS primary endpoint, confirming the safety of glenzocimab in acute ischemic stroke patients
- Reduction in the rate and severity of intracranial hemorrhages and of mortality in glenzocimab-treated patients
Acticor Biotech (FR0014005OJ5 – ALACT), a clinicalstage biotechnology company focused on the development of glenzocimab, an innovative drug for the treatment of cardiovascular emergencies, focusing stroke, announces the publication of phase 1b/2a clinical results of ACTIMIS study in The Lancet Neurology Journal on 23rd, January.
The manuscript is entitled: Safety and efficacy of platelet glycoprotein VI inhibition in acute ischaemic stroke (ACTIMIS): a phase 1b/2a randomized, placebo-controlled, trial
The ACTIMIS clinical trial evaluated glenzocimab in combination with the reference treatment (thrombolysis with or without thrombectomy) in patients presenting with an Acute Ischemic Stroke（AIS）. This publication displays the full analysis of ACTIMIS results.
The key results presented in the manuscript are:
– Achievement of ACTIMIS primary endpoint, confirming the safety of glenzocimab in AIS patients
– In phase 2a, glenzocimab 1000 mg, as add-on therapy to alteplase, was associated with reduced symptomatic intracranial haemorrhage (0% vs 10%) and all-cause mortality (8% vs 21%) compared with placebo.
– Patients with the most severe strokes and at highest risk of intracranial haemorrhage might be the best responders in this study.
Pr. Mikaël Mazighi, MD, PhD, Coordinating Investigator for ACTIMIS and first author of the manuscript, stated: “This is the first time that a randomized clinical trial evaluating an antithrombotic agent in combination with thrombolysis during the acute phase of ischemic stroke has demonstrated a significant reduction in mortality; this is very likely attributed to fewer symptomatic intracerebral hemorrhages. We are looking forward confirming those findings in the ongoing efficacy study ACTISAVE. This breakthrough paves the way for new treatments for patients at the acute phase of ischemic stroke.”
Dr Yannick Pletan, MD, Chief Medical Officer of Acticor Biotech, added: “We are very proud to make the full results of ACTIMIS study publicly available to the scientific community and to gain further insights supporting the dual mode of action of glenzocimab in acute ischemic stroke. In particular, the reduction in intracranial hemorrhages might be a direct consequence of glenzocimab inhibiting microvascular thrombo-inflammation, thereby enhancing ischemic tissue reflow. We believe this reduction underlies the decrease in mortality in glenzocimab-treated patients observed during ACTIMIS study”.
The results of ACTIMIS were first presented during the European Stroke Organisation Conference (ESOC) in 2022. As a reminder, the ongoing phase 2/3 clinical trial ACTISAVE has completed its recruitment in October 2023 with expected results in the second quarter of 2024.