Acticor stops phase 2/3 stroke trial for blood thinner due to futility

Acticor Biotech has decided to halt a phase 2/3 clinical trial evaluating its blood thinning drug, glenzocimab, which was being administered to patients undergoing heart surgery. The decision follows a futility analysis on the initial segment of the trial data. Glenzocimab, an antibody fragment targeting platelet glycoprotein VI (GPVI), has been under scrutiny for its potential to prevent blood clot formation without affecting bleeding regulation, making it a promising candidate for blood clot inhibition.

Approximately 100 patients participated in the study, with the futility analysis based on data from the first 78 individuals. The Independent Monitoring Committee (IMC) reviewed the data and concluded that the study should be discontinued, citing the predefined futility criteria as the basis for their recommendation. Acticor Biotech communicated this decision in a press release.

Glenzocimab, the only asset of Acticor Biotech, has been involved in multiple clinical trials for treating strokes and heart attacks. Despite its promising mechanism, glenzocimab has faced challenges in clinical trials. In a previous phase 2/3 trial conducted in April, the drug did not meet the primary endpoint of reducing severe disability or death following a stroke.

Initial studies had raised hopes for glenzocimab's potential to reduce the risk of uncontrolled bleeding, a common side effect of standard blood thinners like aspirin and Plavix. This optimism was bolstered by a small first-in-human study published in 2019, which indicated favorable results in healthy volunteers.

Further positive outcomes were reported in January 2024, when a phase 1b/2a study demonstrated a reduction in mortality and brain bleeding among stroke patients treated with glenzocimab. These findings sustained the anticipation around the drug's efficacy.

Looking ahead, results from a phase 2b trial focusing on myocardial infarction, commonly known as a heart attack, are anticipated by the end of next year. This forthcoming data will be crucial in determining the future of glenzocimab in the treatment of cardiovascular conditions.