Eli Lilly's cholesterol pill impresses in the test
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A sign with the company logo stands in front of Eli Lilly's headquarters in Indianapolis, Indiana, on March 17, 2024.
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Analysts say Eli Lilly could have a future blockbuster drug his hands: An experimental pill to lower one inherited form of high cholesterol.
The pharmaceutical giant presented data from the mid-stage study of the pill muvalaplin on Monday at the American Heart Association Scientific Sessions meeting in Chicago. The treatment demonstrates the diversity of Eli Lilly's drug pipeline, which extends beyond its top-selling weight loss and diabetes medications.
Here's what makes the daily pill so important: Muvalapline is the only oral drug among several injectable therapies being developed to treat high levels of lipoprotein(a), or Lp(a), in the blood, an innate risk factor for heart disease. These include Eli Lilly's own late-stage injectable drug, lepodisiran, and injections of Novartis And Amgen.
According to the Family Heart Foundation, about one in five Americans, or 63 million people, have elevated Lp(a) levels.
There are currently no approved treatments to lower Lp(a), which can significantly increase the risk of heart attack, stroke and the formation of fatty plaques in the arteries. Lp(a) levels are determined by a person's genes, so lifestyle changes such as diet or exercise have no effect, said Ruth Gimeno, Lilly's group vice president of diabetes and metabolism research, in an interview.
This is different than low-density lipoprotein, also known as LDL or “bad cholesterol,” which can be treated with lifestyle changes and statins.
Let’s dive into the data.
The phase 2 study 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 accurately measures intact Lp(a) particles in the blood.
According to the results, the highest dose of the pill reduced Lp(a) levels by 70% compared to placebo, based on the traditional blood test, and by almost 86% compared to placebo, based on the more specific test.
The 60-milligram dose similarly reduced levels by 81.7% compared to placebo, based on the more 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 pleased with the safety profile of this molecule,” Gimeno said. “There are really no warning signs at all.”
She said the company is discussing next steps for the drug with the FDA, including designing a Phase 3 trial for the pill. Eli Lilly estimates that “it will probably be four or five years before we see the final results of a late-stage trial,” Gimeno noted.
She added that late-stage studies will likely show whether the pill can reduce cardiovascular events such as heart attacks and strokes.
In a research note Tuesday, David Risinger, an analyst at Leerink Partners, said Eli Lilly's pill appears to be competitive with injectable therapies in development based on Phase 2 trial data.
Risinger added that muvalaplin has “megablockbuster potential” if late-stage data shows it can help prevent consequences like heart attacks and strokes before they occur.
He noted that Novartis' experimental injection, pelacarsen, may be the first treatment to show the benefits of lowering Lp(a) levels in reducing cardiovascular risks. The company is expected to release data from a late-stage test of the shot in mid-2025.
Feel free to send tips, suggestions, story ideas and data to Annika at annikakim.constantino@nbcuni.com.
The Latest in Health Tech: Dexcom Invests $75 Million in Oura, Companies Form New Partnership
The Dexcom logo is seen on a smartphone screen and in the background.
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Dexcom announced Tuesday that its glucose biosensors will be compatible with Oura smart rings as part of a new integration. According to a press release, Dexcom also launched Oura's latest funding round with a $75 million investment, valuing the company at more than $5 billion.
Additional investors in the round have not yet been identified, an Oura spokesperson told CNBC.
Oura's rings track sleep, exercise, stress, heart health and other metrics. The company launched new hardware and an updated app last month. Dexcom's continuous glucose monitors are small sensors that pierce the skin to measure blood sugar levels in real time.
The new partnership will allow data to flow between Dexcom and Oura products, allowing users to access a more complete picture of their health, Dexcom said. The first app integration between the two companies will launch in the first half of next year.
Oura and Dexcom will also begin cross-selling and co-promoting their products, the release said.
Dexcom's devices have historically been designed for patients with diabetes, but this year the company has begun moving into more consumer-friendly markets. The company launched a new over-the-counter continuous glucose monitor called Stelo in August that can be used by all adults who don't take insulin. The launch of Stelo means many wearable users, such as Oura customers, will be able to access Dexcom's technology for the first time.
“This strong combination [with Oura] will attract new joint customers who want to better understand the connection between activity, sleep, nutrition and their blood sugar,” Matt Dolan, executive vice president of strategy and corporate development at Dexcom, said in a statement Tuesday.
Oura laid the foundation for its partnership with Dexcom by expressing 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.
Tom Hale, CEO of Oura, called metabolic health the “natural next dimension of the Oura Ring experience” in a blog post following the announcement in September. The company's acquisition of Veri has been completed, the spokesman said.
Read CNBC's review of Oura Ring 4 here. Read CNBC's review of Dexcom's Stelo here.
Feel free to send tips, suggestions, story ideas and data to Ashley at ashley.caroot@nbcuni.com.
