Roche announced today that it had ended development of dalcetrapib, its entry in the once-promising class of HDL-raising CETP inhibitors. A data and safety monitoring board recommended that the dal-OUTCOMES phase 3 trial be stopped due to a lack of clinically meaningful efficacy. The DSMB found no evidence of safety problems.
Here is the press release from Roche:
Roche provides update on Phase III study of dalcetrapib
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that following the results of the second interim analysis of the dalcetrapib dal-OUTCOMES Phase III trial, the independent Data and Safety Monitoring Board (DSMB) has recommended stopping the trial due to a lack of clinically meaningful efficacy. The dal-OUTCOMES trial evaluated the efficacy and safety profile of dalcetrapib when added to existing standard of care in patients with stable coronary heart disease (CHD) following an acute coronary syndrome (ACS). No safety signals relating to the dal-OUTCOMES trial were reported from the DSMB.
“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 M.D., Chief Medical Officer and Head, Global Product Development. “We continue to be fully committed to the development of innovative medicines for people with cardiovascular disease. Our pipeline remains robust with 23 positive late-stage clinical trials reporting over the past 16 months and a significant increase in New Molecular Entities in late-stage development.”
Roche has decided to terminate the dal-OUTCOMES trial and all the studies in the dal-HEART programme. Roche will update all stakeholders further in due course.
About the dal-HEART programme
The dal-HEART is a global development programme involving six clinical trials: dal-OUTCOMES, dal-OUTCOMES 2, dal-PLAQUE 2, dal-ACUTE, dal-PLAQUE (completed) and dal-VESSEL (completed).
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche’s personalized healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2011, Roche had over 80,000 employees worldwide and invested over 8 billion Swiss francs in R&D. The Group posted sales of 42.5 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: http://www.roche.com.
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