Mid-stage Trial Shows Impressive Results for Eli Lilly's Cholesterol Pill

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An experimental pill that lowers an inherited form of high cholesterol may be a future blockbuster drug, according to analysts.

Eli Lilly showcased mid-stage trial data on the pill, muvalaplin, at the American Heart Association Scientific Sessions meeting in Chicago on Monday, highlighting the range of its drug pipeline beyond its top-selling weight loss and diabetes treatments.

The daily pill is crucial because it is the only oral treatment among several injectable therapies being developed to treat high levels of lipoprotein(a) – or Lp(a) – in the blood, an inherited risk factor for heart disease. This includes Eli Lilly's own late-stage injectable drug, lepodisiran, and injections from other companies.

According to the Family Heart Foundation, approximately 63 million Americans have elevated levels of Lp(a).

Currently, there are no approved treatments to lower Lp(a), which significantly increases the risk of heart attack, stroke, and fatty plaque buildup in the arteries. Lp(a) levels are determined by genetics, so lifestyle changes such as diet or exercise have no effect, according to Ruth Gimeno, Lilly's group vice president for diabetes and metabolic research.

Unlike LDL or "bad cholesterol," which can be managed with lifestyle changes and statins, HDL or "good cholesterol" cannot be treated in the same way.

Let's dive into the data.

The phase two trial compared three daily doses of the pill - 10, 60, and 240 milligrams - with a placebo for 12 weeks in adults with high cardiovascular risk due to very high levels of Lp(a). Eli Lilly researchers tested Lp(a) levels using both a traditional blood test and a new method developed by the company that more specifically measures intact Lp(a) particles in the blood.

The traditional blood test showed that the highest dose of the pill decreased Lp(a) levels by 70% compared to the placebo, while the more specific test revealed an almost 86% decrease relative to the placebo.

The 60-milligram dose decreased levels by 81.7% compared to the placebo, while the 10-milligram dose decreased them by 47.6% in a more specific test.

The safety of Eli Lilly's drug was comparable to that of the placebo group in terms of side effects.

"Gimeno stated that the safety profile of the molecule was excellent, with no red flags present."

The company is discussing the next steps for the drug with the FDA, including how to design a phase three trial on the pill. Eli Lilly estimates that "it's probably going to be four or five years until we see the final results" from a late-stage study, Gimeno noted.

Whether the pill can reduce cardiovascular events, such as heart attacks and strokes, will be shown through late-stage trials.

Based on phase two trial data, Eli Lilly's pill appears to be competitive with injectable therapies in development, according to Leerink Partners analyst David Risinger in a research note on Tuesday.

If late-stage data shows that muvalaplin can prevent heart attacks and strokes before they occur, Risinger believes it has "megablockbuster potential."

Novartis' experimental injection, pelacarsen, could potentially be the first treatment to demonstrate the advantages of decreasing Lp(a) levels in minimizing cardiovascular risks. The company plans to unveil data from a late-stage trial on the injection in mid-2025.

Rewritten sentence: Please provide any tips, suggestions, story ideas, and data to Annika at [email protected].

Oura receives $75 million investment from Dexcom, and the two companies form a new partnership in the health-care technology industry.

Dexcom announced that its glucose biosensors will be compatible with Oura's smart rings as part of a new integration. Additionally, Dexcom kicked off Oura's latest funding round by investing $75 million, valuing the company at more than $5 billion, according to a release.

An Oura spokesperson informed CNBC that no additional investors have been decided for the round.

Oura's wearable devices monitor various metrics such as sleep, exercise, stress, and heart health. The company recently released new hardware and updated its app. Dexcom's continuous glucose monitors are compact sensors that penetrate the skin to measure real-time blood sugar levels.

Dexcom and Oura have formed a new partnership to allow data to flow between their products, giving users a more comprehensive view of their health. The first app integration will be launched in the first half of next year.

Oura and Dexcom will collaborate on cross-selling and co-marketing their products, according to the release.

Dexcom has traditionally focused on designing devices for diabetes patients, but this year the company has expanded into consumer-friendly markets. In August, Dexcom released an over-the-counter continuous glucose monitor called Stelo, which is accessible to any adults who do not take insulin. With the launch of Stelo, many wearable users, such as Oura customers, can now utilize Dexcom's technology for the first time.

Dexcom's executive vice president of strategy and corporate development, Matt Dolan, stated on Tuesday that this potent collaboration with Oura will draw in new shared customers seeking to comprehend the correlation between activity, sleep, nutrition, and their glucose levels.

Oura has announced its acquisition of Veri, a company that uses continuous glucose monitors to help users eat healthier and lose weight, signaling its interest in the metabolic health space.

Oura CEO Tom Hale stated in a blog post that metabolic health is the "natural next dimension of the Oura Ring experience" after the company's acquisition of Veri was completed.

CNBC has published reviews of the Oura Ring 4 and Dexcom's Stelo.

Rewritten sentence: Please provide any tips, suggestions, story ideas, and data to Ashley at [email protected].