Clinical stage biopharmaceutical company Acticor Biotech (Euronext Growth Paris:ALACT) announced on Tuesday the publication of phase 1b/2a clinical results of the ACTIMIS study in The Lancet Neurology Journal.
ACTIMIS assessed glenzocimab, an innovative drug for the treatment of cardiovascular emergencies, in combination with the reference treatment (thrombolysis with or without thrombectomy) in patients presenting with an Acute Ischemic Stroke (AIS).
Key findings include the confirmation of glenzocimab's safety in AIS patients, particularly in phase 2a, where the 1000 mg dosage, as an add-on to alteplase, demonstrated reduced symptomatic intracranial haemorrhage (0% vs. 10%) and all-cause mortality (8% vs. 21%) compared to placebo. Notably, patients with severe strokes and higher intracranial haemorrhage risk showed promising responses.
Pr. Mikaël Mazighi, MD, PhD, coordinating investigator for ACTIMIS and first author of the manuscript, said: "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 haemorrhages. We are looking forward confirming those findings in the ongoing efficacy study ACTISAVE."
The manuscript is titled 'Safety and efficacy of platelet glycoprotein VI inhibition in acute ischaemic stroke (ACTIMIS): a phase 1b/2a randomized, placebo-controlled, trial'.
Results from the phase 2/3 trial ACTISAVE are expected in the second quarter of 2024.
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