By Bill Alpert

Lingering doubts about Merck's experimental heart pill pretty much vanished Sunday, when the drugmaker showed it cut levels of harmful LDL cholesterol as effectively as today's injectable drugs.

The once-daily pill reduced LDL by 56% in just six months, among a couple of hundred test patients whose inherited high-levels of LDL defy treatment with everyday statin drugs. That's on a par with costly injectable antibody drugs like Repatha from Amgen, Praluent from Regeneron and Sanofi, and Leqvio from Novartis -- all of which inhibit a basic cholesterol trigger known as PCSK9. The Merck drug, enlicitide, inhibits PCSK9, yet comes in a pill form that's cheaper to make and easier to take.

Some skepticism surrounded the Merck pill's earlier drug trials, because patients can't eat for eight hours before swallowing it, and must avoid certain other drugs. Those conditions proved no hindrance to enlicitide achieving a 62% reduction in LDL after a year's time, while also greatly reducing other artery-damaging molecules like apolipoprotein B and lipoprotein(a). It had no more side effects or study dropouts than the placebo pill received by the control participants.

AstraZeneca is developing a pill that won't require an empty stomach, but the success of Merck's Phase pivotal 3 study suggests that the difference may not much matter. Some 97% of Merck study patients were compliant. Merck is further along in its clinical trials, and will file early next year for approval by the U.S. Food and Drug Administration. Sales could begin in 2027.

In midday trading Monday, Merck shares were up 0.2%, to $86.45, in line with the broader market. The stock is up 30% since the early June announcement when Merck pronounced the enlicitide study a success, without giving any data. AstraZeneca stock was up 2.4% Monday to $86.65.

Merck's news emerged at the annual science meeting of the American Heart Association. Other companies also reported encouraging results there for the new generation of drugs that's resulting from a renaissance in artery disease research.

The value of reducing PCSK9 was validated by a 12,000-person study reported by Amgen, in which its Repatha injectable drug reduced heart attacks, strokes and cardiac deaths by 25% over five years, compared with a control group. The tested patients had statin-resistant cholesterol levels and suffered either atherosclerosis or diabetes. A large study that's testing the preventive power of Merck's pill won't report for a couple more years, but Amgen's study shows that PCSK9 inhibition works.

Another demonstration of preventive prowess came from Ionis Pharmaceuticals, which showed AHA attendees Phase 3 data on its triglyceride-cutting drug olezarsen. High-levels of those fatty molecules often send patients to the hospital with painful pancreatitis. The Ionis injectable drug cut those pancreatitis attacks by over 80%.

With the first triglyceride-lowering drug to show clear preventive benefits, Ionis drew cheers among analysts who predicted sales of $1 billion in their Monday morning notes. Traders seemed less smitten, and the stock traded off 4% to a Monday afternoon price of $7.80.

A permanent fix for the pesky PCSK9 was described by Crispr Therapeutics, which reported LDL drops of as much as 87%, and triglyceride drops of up to 84% in the Phase 1 study of its gene-editing treatment CTX310. No serious side effects were linked to the treatment. Crispr shares were down 1% by mid-Monday, to $54.58.

Another firm developing a one-and-done gene edit for cholesterol, Verve Therapeutics, was acquired in July for $1.3 billion by Eli Lilly.

Write to Bill Alpert at william.alpert@barrons.com

This content was created by Barron's, which is operated by Dow Jones & Co. Barron's is published independently from Dow Jones Newswires and The Wall Street Journal.

(END) Dow Jones Newswires

November 10, 2025 16:20 ET (21:20 GMT)

Copyright (c) 2025 Dow Jones & Company, Inc.