Phase II/III stroke treatment trial.
Acticor Biotech has enrolled the first US subject in the Phase II/III ACTISAVE clinical trial of glenzocimab in acute ischemic stroke patients.
The first subject in the US was enrolled at the CHI Memorial Stroke and Neuroscience Center, Chattanooga, Tennessee.
In November last year, the company received clearance from the US Food and Drug Administration (FDA) for the Investigational New Drug (IND) application to commence the trial.
Acticor began subject enrollment in Europe in the third quarter of last year.
The randomized, adaptive, multinational, multicentre, double-blind, placebo-controlled, parallel-group trial will assess the safety and efficacy of one dose of glenzocimab plus standard of care (thrombolysis +/- thrombectomy) to treat acute ischemic stroke.
It has so far enrolled 130 subjects.
This registration trial intends to enroll a total of 1,000 subjects at nearly 80 centres in the US, France, Belgium, Spain, Germany, Denmark, Czech Republic, Slovakia, Great Britain, and Israel.
Acticor will conduct an initial futility assessment on enrolling the first 200 subjects to validate the initial hypotheses.
Acticor Biotech chief operating officer and chief medical officer Dr Yannick PLETAN said: “The opening of the first US centres, in addition to those already active in Europe, marks another important milestone for our ACTISAVE Phase II/III study.
“The cumulative incidence of ischemic stroke in the USA, Europe, Japan, and China will approach four million patients by 2026, highlighting the urgent need for an effective treatment to address this major public health problem with a strong societal and economic impact.”
In July this year, the European Medicines Agency awarded Priority Medicines (PRIME) status for glenzocimab to treat stroke, recognizing its possible clinical benefit.