After underwhelming results, Roche has pulled its second analysis of the dalcetrapib dal-OUTCOMES Phase III trial after the Data and Safety Monitoring Board (DSMB) pinpointed the trial's “lack of clinically meaningful efficacy.”
The trial aimed to evaluate the efficacy and safety of dalcetrapib when it was added to standard care in patients with stable coronary heart disease after acute coronary syndrome. Dalcetrapib, a cholesteryl ester transfer protein (CETP) inhibitor, works to increase high density lipoprotein cholesterol (HDL-C) levels in plasma by preventing the transport of HDL-C to very low-density lipoprotein/low-density lipoprotein.
Basel, Switzerland-based Roche said it will stop all six trials in the dal-HEART program: dal-OUTCOMES, dal-OUTCOMES 2, dal-PLAQUE 2, dal-ACUTE, dal-PLAQUE and dal-VESSEL.
No safety signals have been reported by the DSMB relating to the dal-OUTCOMES trial.
“Lowering cardiovascular risk beyond that which is achieved with intensive statin treatment is a very challenging goal and while we have always stated that dalcetrapib is a high-risk project, we are disappointed by the fact that this drug didn't provide benefit to the patients in our study,” said Hal Barron MD, chief medical officer and head of global product development, in a statement. He added that the company remained committed to developing new medicines for people with cardiovascular disease.