Merck & Co., Inc. (MRK - Free Report) announced detailed data from a large phase III cardiovascular outcomes study (REVEAL) evaluating anacetrapib, a cholesteryl ester transfer protein (CETP) inhibitor in patients with cardiovascular disease.
Data from the phase III study showed that anacetrapib and a statin reduced the risk of major coronary events (composite of coronary death, myocardial infarction, and coronary revascularization) by 9% relative to placebo in patients with atherosclerotic vascular disease who are already receiving an effective cholesterol treatment. While anacetrapib reduced the risk to 10.8%, the same was 11.8% for patients on a placebo and a statin. However, no significant benefit was observed in reducing the risk of ischemic stroke.
The detailed data were published in the New England Journal of Medicine and presented at the European Society of Cardiology Congress.
Merck’s shares have risen 7.2% this year so far, comparing unfavorably with an 11.2% increase for the industry.
Top-line data from the study was announced in June 2017 wherein the company said that the study had met the primary endpoint. It also said that the CETP inhibitorled to significant reduction in major coronary eventsversus placebo in patients at high risk of cardiovascular events who are already receiving an effective cholesterol treatment. However, the details have only been mentioned now.
The company-funded REVEAL study was conducted in more than 30,000 patients who were taking atorvastatin – a common medicine for lowering "bad" cholesterol or LDL - for a median duration of at least four years.
It was also said that anacetrapib’s safety profile was in line with that observed in previous studies with the most significant side effect being the accumulation of anacetrapib in adipose or fat tissue for years after taking the drug.
As announced in June, Merck is not sure whether the data are strong enough to seek approval and plans to review the results with external experts. The company will then consider whether to file regulatory applications with the FDA and other agencies.
We remind investors that three previous experimental CETP inhibitors had failed in their respective studies. CETP inhibitors are designed to raise HDL-cholesterol levels or what is known as “good” cholesterol.
In 2015, Eli Lilly and Company (LLY - Free Report) terminated the development of its late-stage CETP inhibitor, evacetrapib based on the recommendation of an independent data monitoring committee, which suggested that chances of meeting the primary endpoint were low. Back in 2006, Pfizer, Inc. (PFE - Free Report) had suspended the late-stage development of its CETP inhibitor, torceptrapib, due to safety issues. In 2012, Roche (RHHBY - Free Report) discontinued the development of its CETP inhibitor, dalcetrapib, due to lack of efficacy.
However, uncertainty regarding whether or not the company will actually file the data with regulators remains. It is apprehended that the accumulation of anacetrapib in fat tissues could get in the way of regulatory approval.
Merck carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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