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A sign with the company's logo sits outside Eli Lilly's headquarters in Indianapolis, Indiana, on March 17, 2024.
Scott Olson | fake images
Analysts say Eli Lilly may have a future highly successful drug on the market in your hands: an experimental pill designed to reduce inherited form of high cholesterol.
The pharmaceutical giant presented data from the mid-stage trial of the pill muvalaplin at the American Heart Association's Scientific Sessions meeting in Chicago on Monday. The treatment demonstrates the diversity of Eli Lilly's drug portfolio beyond its best-selling diabetes and weight loss treatments.
This is what makes the daily pill so important: Muvalaplin is the only oral treatment among several injectable therapies being developed to treat high levels of lipoprotein (a) – or Lp (a) – in the blood, a factor hereditary risk of heart disease. This includes Eli Lilly's late-stage injectable drug, lepodisiran, and injections of Novartis and amgen.
About one in five Americans, or 63 million people, have elevated levels of Lp(a), according to the Family Heart Foundation.
There are currently no approved treatments to lower Lp(a), which can significantly increase the risk of heart attack, stroke, and fatty plaque buildup in the arteries. Lp(a) levels are determined by a person's genes, so lifestyle changes, such as diet or exercise, have no effect, Ruth Gimeno, vice president of the group, said in an interview. Lilly metabolic and diabetes research.
This is different from low-density lipoprotein, also known as LDL or “bad cholesterol,” which can be treated with lifestyle changes and statins.
Let's dig 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 at high cardiovascular risk due to very high Lp(a) levels. 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 highest dose of the pill decreased Lp(a) levels by 70% compared to placebo based on the traditional blood test, and almost 86% relative to placebo based on the more specific test, according to the results.
The 60 milligram dose also reduced levels by 81.7% compared to placebo according to the most specific test, while the 10 milligram dose reduced them by 47.6%.
In terms of safety, side effects were similar between those who received Eli Lilly's drug and the placebo group.
“We were very, very happy with the safety profile of this molecule,” Gimeno said. “There's really no red flag.”
He said the company is discussing next steps for the drug with the FDA, including how to design a phase three trial on the pill. Eli Lilly estimates that “it will probably be four or five years until we see the final results” of a late-stage study, Gimeno said.
He added that late-stage trials will likely show whether the pill can reduce cardiovascular events, such as heart attacks and strokes.
In a research note Tuesday, Leerink Partners analyst David Risinger said Eli Lilly's pill appears to be competitive with injectable therapies in development based on phase two trial data.
Risinger added that muvalaplin has “blockbuster potential” if late-stage data show it can help prevent outcomes like heart attacks and strokes before they happen.
He noted that Novartis' experimental injection, pelacarsen, could be the first treatment to show the benefits of lowering Lp(a) levels to reduce cardiovascular risks. The company is scheduled to release data from a late-stage trial of the shot in mid-2025.
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The Latest in Healthcare Tech: Dexcom Invests $75 Million in Oura, Companies Sign New Partnership
The Dexcom logo is seen on a smartphone screen and in the background.
Pavlo Gonchar | SOPA Images | Light rocket | fake images
dexcom announced Tuesday that its glucose biosensors will be compatible with Oura smart rings as part of a new integration. Dexcom also kicked off Oura's latest funding round by investing $75 million, valuing the company at more than $5 billion, according to a statement.
No additional investors in the round have been determined, an Oura spokesperson told CNBC.
Oura rings track sleep, exercise, stress, heart health, and other metrics. The company launched new hardware and an updated app last month. Dexcom continuous glucose monitors are small sensors that pass through the skin to measure blood sugar levels in real time.
Through the new partnership, data will flow between Dexcom and Oura products so users can access a more complete picture of their health, Dexcom said. The first application integration between the two companies will be launched in the first half of next year.
Oura and Dexcom will also begin cross-selling and co-marketing their products, according to the statement.
Dexcom devices have historically been designed for patients with diabetes, but this year they have begun to enter more consumer-friendly markets. In August, the company launched a new over-the-counter continuous glucose monitor called Stelo, which can be used by any adult who does not take insulin. The launch of Stelo means that many wearable users, such as Oura customers, can access Dexcom's technology for the first time.
“This powerful combination [with Oura] will attract new shared customers who want to better understand the link between activity, sleep, nutrition and their glucose,” Matt Dolan, executive vice president of strategy and corporate development at Dexcom, said in a statement Tuesday.
Oura laid the groundwork for its partnership with Dexcom by signaling its interest in the metabolic health space this year. In September, Oura announced that it had agreed to acquire Veri, a company that uses continuous glucose monitors to help users eat healthier and lose weight.
Oura CEO Tom Hale called metabolic health the “next natural dimension of the Oura Ring experience,” in a blog post following the September announcement. The company's acquisition of Veri has been completed, the spokesperson said.
Read CNBC's review of Oura Ring 4 here. Read CNBC's review of Dexcom's Stelo here.
Please feel free to send any tips, suggestions, story ideas, or information to Ashley at [email protected].
