Merck ($MRK), the last Big Pharma standing in CETP inhibition, is pressing forward with a huge cardiovascular trial after getting the green light from its independent advisers, stepping over the scattered failures of similar projects in hopes of hitting upon a blockbuster.
The drug, anacetrapib, is designed to ward off heart attacks and strokes by blocking the protein CETP and thus boosting HDL, or "good," cholesterol. After witnessing rival programs from Pfizer ($PFE), Roche ($RHHBY) and, most recently, Eli Lilly ($LLY) go down in Phase III, Merck added a planned futility analysis to its 30,000-patient trial, allowing investigators to take an early peek at safety and efficacy data before the study wraps in 2017.
The committee has now completed its review and recommended no changes to the anacetrapib program, Merck said, leaving the company, which is blinded to to the data, to soldier on.
Merck has no further interim analyses planned for anacetrapib and is effectively locked in for the costly study. Lilly, which pulled the plug on its CETP drug evacetrapib last month, scheduled a handful of periodic data reviews in its Phase III program and didn't nix the study until after the second.
Years ago, CETP blockade was widely tapped as the next big thing in cardiovascular therapy, with blockbuster expectations for each major project. Then, in 2006, Pfizer halted Phase III development of its torcetrapib after spotting some alarming safety issues. About 5 years later, Roche pulled the plug on the similar dalcetrapib after finding little evidence of benefit in an interim analysis of its own. Then came Lilly's exit in October.
But yet the CETP hypothesis lives on. Beyond Merck's massive program, Amgen ($AMGN) bought into the field earlier this year with a $1.6 billion deal for Dezima and its oral CETP treatment, viewing the therapy as a potential complement to the cholesterol-lowering injectable Repatha.
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