Promising mid-stage data on apixaban in ACS

US drug majors Bristol-Myers Squibb and Pfizer have reported encouraging results from APPRAISE-1, a Phase II dose-ranging study testing their investigational drug apixaban in patients with acute coronary syndrome. The trial compared the current standard-of-care for ACS, including aspirin and clopidogrel, with apixaban plus the standard-of-care. Results from the mid-stage study were presented during a late-breaking session at the annual European Society of Cardiology meeting, held in Munich, Germany.

Apixaban is an oral, highly-selective factor Xa inhibitor, a new class of agents with therapeutic potential to prevent and treat blood clots in the veins and arteries. The six-month APPRAISE-1 study was not powered to demonstrate significance on the composite efficacy endpoint of cardiovascular death, non-fatal heart attack, severe recurrent ischemia and non-hemorrhagic stroke. However, there was a non-significant relative risk reduction compared to placebo (n=611) of 27% for 2.5mg twice daily (n=317) and 39% for 10mg once daily (n= 318) doses.

The incidence of the primary endpoint of this safety study, major bleeding plus clinically-relevant non-major bleeding, was 5.7% for apixaban patients who took the 2.5mg twice-daily dose (n=315), 7.9% for subjects given the 10mg once daily dose (n=315), and 3.0% those who took placebo (n=599).