BioCentury
ARTICLE | Clinical News

Dalcetrapib: Development discontinued

May 14, 2012 7:00 AM UTC

Roche discontinued development of cardiovascular compound dalcetrapib due to a "lack of clinically meaningful efficacy" in a second interim analysis of the double-blind, placebo-controlled, international Phase III dal-OUTCOMES trial in >15,000 patients with stable CHD following a recent acute coronary syndrome (ACS). The pharma made the decision based on a recommendation from the study's DSMB, which said that once-daily 600 mg oral dalcetrapib plus standard of care would not show a 15% reduction on the composite primary endpoint of time to first occurrence of CHD death, non-fatal acute MI, hospitalization for unstable angina, resuscitated cardiac arrest or stroke vs. placebo plus standard of care. No safety signals were reported. SOC included management of LDL-C and best evidence-based medical care. All remaining studies in the dal-HEART development program - the Phase III dal-OUTCOMES 2, dal-ACUTE and dal-PLAQUE 2 trials - of dalcetrapib have been terminated. ...