Roche Holding AG (RHHBY.PK) has decided to terminate the dal-OUTCOMES trial and all the studies in the dal-HEART program after the independent Data and Safety Monitoring Board or DSMB recommended stopping the trial due to a lack of clinically meaningful efficacy.
The DSMB's recommendation came after the results of the second interim analysis of the dalcetrapib dal-OUTCOMES Phase III trial, the Swiss drugmaker said.
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 following an acute coronary syndrome. The DSMB did not report any safety signals relating to the trial.
According to Roche's website, dalcetrapib is an oral, small molecule cholesteryl ester transfer protein modulator which targets HDL or the "good cholesterol." Studies have shown that dalcetrapib may improve the ability of HDL to remove cholesterol from cells. The hypothesis that these effects may prevent future cardio vascular events is being assessed in the pivotal Phase III study, dal-OUTCOMES.
The company had reportedly pinned hopes on dalcetrapib, which was expected to be introduced by 2016. It was expected to generate around $1.1 billion.
Hal Barron, Chief Medical Officer and Head, Global Product Development, said, "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."
Roche has now decided to terminate the dal-OUTCOMES trial and all the studies in the dal-HEART program. The company will update stakeholders further in due course.
The stock is falling 3.75 percent in Zurich at 158.90 euros.
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by RTT Staff Writer
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