Hit by trial setbacks and failures that have blighted the entire class, Merck is mulling whether to file its cholesteryl ester transfer protein (CETP) medication anacetrapib after posting some surprising positive topline data from the Reveal test.
Remarkably, anacetrapib met its primary endpoint, significantly reducing major coronary events, such as coronary death, heart attack and coronary revascularization, compared to a dummy pill. The test was conducted with patients that have a risk for cardiac events who are on a lipid-lowering statin.
This is a major turnaround, given that many in the field had written off Merck’s chances of this CETP inhibitor ever getting to market after a series of misfires in testing, and comes after many of its rivals had already given up the ghost.
Anacetrapib is designed to ward off heart attacks and strokes by blocking the protein CETP and thus boosting HDL, or “good,” cholesterol. But rival programs from Pfizer, Roche and Eli Lilly all went belly-up in phase 3, with safety issues—a major problem in cardiovascular R&D—raising their heads time and time again.
Back in 2015, Merck laid out a futility analysis to its 30,000-patient Reveal trial as its last-ditch effort, saying data would be out in 2017.
Last year, after another setback for Lilly, Stephen Nicholls, deputy director of the South Australian Health and Medical Research Institute in Adelaide, Australia, and lead investigator for the failed trial of Lilly’s drug said, “Merck’s drug is the fourth shot on goal for CETP inhibitors, but with disappointment or lack of success for the other agents you have to be increasingly pessimistic.” It seems there may just be a glimmer after all.
But what about Merck’s safety profile? “In the early analysis was generally consistent with that demonstrated in previous studies of the drug, including accumulation of anacetrapib in adipose tissue, as has been previously reported,” the company said in a release. Full details aren’t coming until the end of August, where eyes will be peeled on a breakdown of the data, and its safety. For now, investors were reasonably happy, with Merck’s shares up around 2.5% premarket on the news.
The U.S. Big Pharma remains cautiously optimistic, and said in a brief update that it “will consider whether to file new drug applications with the FDA and other regulatory agencies.”
Analysts at Jefferies were just as hesitant, saying in a note to clients, "The cautious language in the release indicates an unclear risk:benefit in our view, which investors should pay attention to."
The analyst firm added that filing remains uncertain: "We have previously highlighted low expectations for Reveal, given the prior failures of other products in the CETP class, only assigning a 25% probability of success in our model."