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An experimental pill from Merck & Co. may lower cholesterol as powerfully as similar injectable drugs from Amgen and Regeneron, according to study results presented at a medical meeting this past weekend.
In one Phase 3 trial, treatment with the drug, known as enlicitide, reduced low-density lipoprotein or “bad” cholesterol by 56% after six months in people at risk of heart attacks, strokes and other cardiovascular complications. In the other, which evaluated enlicitide in those with a genetic form of high cholesterol, enlicitide dropped LDL-C by 59% compared to a placebo after 24 weeks.
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Merck intends to share the results with the Food and Drug Administration and other global regulators.
In the larger of the two studies, Merck enrolled more than 2,900 people who’d either previously had a cardiovascular event like a heart attack or were at risk of one because of high LDL-C levels or other health problems. They were randomized to take either enlicitide or a placebo every day on top of their regular cholesterol-lowering medications.
The LDL-C lowering of 56% compared to the study’s start hit the study’s main objective and was largely maintained. Longer-term follow-up indicated LDL-C levels were 48% lower after a year. Placebo recipients, by comparison, had a slight increase.
The second study result Merck unveiled randomized 303 people with heterozygous familial hypercholesterolemia and gave them either enlicitide alongside their existing medications or a placebo. In that study, enlicitide’s cholesterol-lowering effects were also sustained, with treatment leading to a 61.5% reduction compared to a placebo after a year.
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Enlicitide is being positioned as a more convenient alternative to Amgen’s Repatha and Sanofi and Regeneron Pharmaceuticals’ Praluent, antibody drugs that similarly target the cholesterol-regulating protein PCSK9. Unlike those drugs, enlicitide is taken orally and should be less expensive to manufacture, enabling the company to potentially sell it at a lower price.
The data Merck presented Saturday at the American Heart Association meeting are a step towards that goal. In a note to clients, for instance, Leerink Partners’ Daina Graybosch wrote that data should show physicians that enlicitide and injectable PCSK9 drugs are “largely interchangeable.” Competitive pricing and an ability to be stored at room temperature could also help Merck’s medicine gain market share, Graybosch wrote.
In a statement provided by Merck, study investigator Ann Marie Navar, a medical professor at UT Southwestern Medical Center, added that the majority of patients still don’t reach their LDL-C goals despite the availability of other treatments.
“Enlicitide has the potential to help close gaps in achievement of lipid goals in patients with and at risk for cardiovascular events and ultimately help address the ongoing [cardiovascular] epidemic,” she added.
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But the results so far would likely only qualify enlicitide for limited approval, as the drug hasn’t yet proven it can protect heart health like its injectable counterparts. Merck is currently running a study that’s testing how well it can. Repatha has also recently shown it can help patients when used as a “primary prevention” therapy, which could soon enable broader use.
William Blair analyst Matt Phipps has additionally noted that patient adherence could be an issue with enlicitide, as patients have to fast for a short time before or after taking the therapy for it to be most effective.