Merck has unveiled a new pill that slashes "bad" LDL cholesterol—by at least half in two-thirds of patients, per STAT News—opening the door to a future where heart attack and stroke risk could plummet for millions. The drug, called enlicitide, targets a liver protein known as PCSK9, which normally slows the body's ability to clear cholesterol. By blocking PCSK9, enlicitide drives LDL down by as much as 60%—on par with biweekly or monthly injections of monoclonal antibodies, but in a once-daily pill, the New York Times reports.
Merck unveiled the results of a 24-week study at an American Heart Association meeting Saturday, showing that enlicitide reduced LDL by up to 60% in nearly 3,000 high-risk patients, with no difference in side effects compared to a placebo. Patients saw levels fall by up to 20% in the first year alone. The new medication could be a breakthrough for the estimated 6 million Americans eligible for PCSK9 blockers. Currently, less than 1% take the injectable versions, like Praluent or Repatha, partly because of cost (over $500 a month) and the hassle of regular injections. Merck's goal: make enlicitide cheap and easy enough that taking it would be "no different than aspirin," says Merck's research president, Dean Li, who calls it a potential "game changer" for public health, per the Times.
Developing a PCSK9 pill was considered nearly impossible because the protein's large, flat surface made it hard for small molecules (as opposed to larger antibodies) to latch on. Merck spent a decade on the problem and ultimately built a ring of peptides, bigger than a typical pill-delivered molecule, to do the job. That innovation could open the door to oral versions of other injected drugs, the company says. It's continuing to test the pill but plans to seek FDA approval early next year. AstraZeneca is also developing a PCSK9 pill, the Times notes.