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Development of dalcetrapib terminated
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Roche today announced the decision to terminate the dal-OUTCOMES trial and has ended the development of the CETP inhibitor dalcetrapib, according to a press release.
Results of the second interim analysis of the dal-OUTCOMES trial showed a lack of clinically meaningful efficacy, leading the Data and Safety Monitoring Board to recommend termination of the trial. No safety signals relating to the trial were reported.
“Lowering CV 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,” Hal Barron, MD, chief medical officer and head of Global Product Development, said in a press release.
The trial evaluated the efficacy and safety profile of dalcetrapib (Roche) when added to existing standard of care in patients with stable CHD following an acute coronary syndrome. Along with the termination of this trial, Roche announced the termination of all the studies in the dal-HEART program.