DSMB recommended canning trial due to lack of clinical efficacy.
Roche is pulling the plug on the dal-Heart development program for its Phase III-stage CETP modulator dalcetrapib. The decision to end the program followed an independent data and safety monitoring board’s recommendation that one of the studies in patients with coronary heart disease (CHD) did not show clinically meaningful efficacy.
The dal-Outcomes study had been evaluating whether combining dalcetrapib in combination with existing standard of care could lower the incidence of additional cardiovascular events in over 15,000 patients with stable coronary heart disease following an acute coronary syndrome.
“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 patients in our study,” admits Hal Barron, M.D., CMP and head of global product development at Roche.
The global dal-Heart development program for dalcetrapib had involved six clinical trials including two completed studies, dal-Plaque and dal-Vessel. Positive data from both the Phase IIb mechanistic studies in CHD patients were reported in 2011.
