Merck's CETP Inhibitor Reduces CV Risk In Phase III Study

Merck & Co., Inc. (NYSE:MRK) announced that a large late-stage cardiovascular outcomes study (REVEAL) evaluating anacetrapib, a cholesterol-lowering medicine, met the primary endpoint by reducing cardiovascular (CV) risk.

Top-line data from the phase III study showed that anacetrapib, a cholesteryl ester transfer protein (CETP) inhibitor, led to significant reduction in major coronary events (composite of coronary death, myocardial infarction, and coronary revascularization) versus placebo in patients at high risk of cardiovascular events who are already receiving an effective cholesterol treatment. 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.

Merck’s shares are up 11.3% year to date, comparing unfavorably with an increase of 14.9% witnessed by the Zacks classified Large-Cap Pharma industry.

The company-funded REVEAL study was conducted in approximately 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.

Detailed results from the study are expected to be presented at a medical conference in Europe in August. 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.

The positive results from the REVEAL study were a surprise because three previous experimental CETP inhibitors had failed. CETP inhibitors are designed to raise HDL-cholesterol levels or what is known as “good” cholesterol.

In 2015, Eli Lilly and Company (NYSE:LLY) 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. (NYSE:PFE) had suspended the late-stage development of its CETP inhibitor, torceptrapib, due to safety issues. Then in 2012, Roche (OTC:RHHBY) 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 has raised investor concern. 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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