Roche reports Phase II inclacumab data

Roche (SIX:ROG; OTCQX:RHHBY) said a single IV infusion of 20 mg/kg inclacumab was associated with a "strong trend" but missed the co-primary endpoints in the Phase II SELECT-ACS trial to reduce myocardial damage during percutaneous coronary intervention (PCI) in 322 evaluable patients with non-ST-elevation myocardial infarction (NSTEMI). Inclacumab missed the co-primary endpoints of reducing cardiac troponin I levels from baseline to 16 hours post-PCI (placebo-adjusted geometric mean reduction of 22.4%, p=0.066) and to 24 hours post-PCI vs. placebo (placebo-adjusted geometric mean reduction of 24.4%, p=0.053). A single IV infusion of 5 mg/kg inclacumab missed both co-primary endpoints. Data were published in the Journal of the American College of Cardiology and presented at the American College of Cardiology meeting in San Francisco.

Roche said the data warrant further clinical testing of inclacumab in acute MI. The pharma is assessing a Phase III program and plans to announce further details this year. Next half, Roche expects data from the Phase II SELECT-CABG trial evaluating inclacumab vs. placebo to prevent saphenous vein graft disease in patients undergoing elective or urgent coronary artery bypass graft (CABG) surgery. ...