Roche abandons Phase III cholesterol drug
pharmafile | May 8, 2012 | News story | Medical Communications, Research and Development, Sales and Marketing | CETP inhibitor, Roche, cardiovascular, dalcetrapib, phase III failure
Roche has abandoned its Phase III cholesterol treatment dalcetrapib after disappointing results.
The manufacturer is ceasing work on the drug, once touted as a potential blockbuster, “due to a lack of clinically meaningful efficacy”.
The failure creates a major hole in Roche’s late-stage pipeline, and has wiped several percentage points off the company’s share price.
The decision to abandon the drug came after a second interim analysis of the data suggested it could not outperform intensive statin therapy, the current standard treatment.
“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, the Swiss group’s chief medical officer.
The dal-OUTCOMES Phase III trial added dalcetrapib to the existing standard of care in patients with stable coronary heart disease following an acute coronary syndrome. There were no reported safety issues with the drug.
As well as terminating dal-OUTCOMES, Roche is also calling a halt to the other studies in its dal-HEART programme: dal-OUTCOMES 2, dal-PLAQUE 2 and dal-ACUTE.
Two more, dal-PLAQUE and dal-VESSEL, have already been completed.
“We continue to be fully committed to the development of innovative medicines for people with cardiovascular disease,” Barron said.
The failure of dalcetrapib is particularly disappointing for Roche because it was part of a move to branch out into therapy areas in which it was not established.
The drug is in the same CETP inhibitor class as Pfizer’s torcetrapib, which also reached Phase III development, before Pfizer abandoned it because of safety concerns in 2007.
In a statement, Barron remained upbeat: “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,” he said.
Adam Hill
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