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A banner bearing the company's logo outside Eli Lilly's headquarters in Indianapolis, Indiana, on March 17, 2024.
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Analysts say Eli Lilly She may have a future hit drug on her hands: an experimental pill designed to lower a hereditary form of high cholesterol.
The pharmaceutical giant presented mid-stage trial data on its birth control pill, movalablin, at the American Heart Association's Scientific Sessions meeting in Chicago on Monday. The treatment showcases the diversity of Eli Lilly's drug product line beyond its best-selling weight loss and diabetes treatments.
Here's what makes the daily pill so important: movalablin is the only oral treatment among several injectable therapies being developed to treat high levels of lipoprotein(a) — or lipoprotein(a) — in the blood, a genetic risk factor for disease. the heart. This includes Eli Lilly's late-stage injectable drug, lipodesiran, and its injections Novartis and Amgen.
About one in five Americans, or 63 million people, have high 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 attacks, strokes, and fatty plaque buildup in the arteries. Lp(a) levels are determined by a person's genes, so lifestyle changes like diet or exercise have no effect, Ruth Jimeno, MD, vice president of Lilly's diabetes and metabolic research group, said in an interview.
This is in contrast to low-density lipoprotein, also known as LDL or “bad cholesterol,” which can be treated with lifestyle changes and taking statins.
Let's dive into the data.
The phase 2 trial compared three daily doses of the pill — 10, 60 and 240 milligrams — with a placebo for 12 weeks in adults with a high risk of cardiovascular disease due to very high levels of Lp(a). Eli Lilly researchers tested Lp(a) levels using a traditional blood test and a new method developed by the company that more specifically measures intact Lp(a) molecules in the blood.
The highest dose of the pill reduced Lp(a) levels by about 70% compared to placebo based on the traditional blood test, and about 86% compared to placebo based on the more specific test, according to the results.
Likewise, the 60-milligram dose reduced levels by 81.7% compared to placebo based on more specific testing, while the 10-milligram dose reduced them by 47.6%.
In terms of safety, side effects were similar between those who received Eli Lilly and the placebo group.
“We were very pleased with the safety profile of this molecule,” Jimeno said. “There are no red flags at all.”
She said the company is discussing next steps for the drug with the Food and Drug Administration, including how to design a phase 3 trial on the pill. Jimeno noted that Eli Lilly estimates that “it will likely take four or five years until we see final results” from a late-stage study.
She added that late-stage trials are likely to show whether the pill can reduce cardiovascular disease, such as heart attacks and strokes.
In a research note Tuesday, Leerink Partners analyst David Reisinger said Eli Lilly's pills appear competitive with injectable treatments in development based on phase 2 trial data.
Reisinger added that movalablin has “tremendous 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, belacarcin, could be the first treatment to show the benefits of lowering Lp(a) levels in reducing cardiovascular risk. The company is scheduled to publish data from a late-stage trial of the injection in mid-2025.
Feel free to send any tips, suggestions, story ideas and data to Annika at annikakim.constantino@nbcuni.com.
Cutting-edge healthcare technology: Dexcom invests $75 million in Oura, companies strike new partnership
The Dexcom logo appears on the smartphone screen and in the background.
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Discom It announced Tuesday that its glucose biosensors will be compatible with Oura smart rings as part of the new integration. Dexcom also kicked off Oura's latest funding round with a $75 million investment, valuing the company at more than $5 billion, according to a statement.
An Oura spokesperson told CNBC that no additional investors have been identified in the round.
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 penetrate the skin to measure blood sugar levels in real time.
Through the new partnership, data will flow between Dexcom and Ora products so users can 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-marketing their products, the statement said.
Dexcom devices have historically been designed for patients with diabetes, but they began entering more consumer-friendly markets this year. In August, the company released a new over-the-counter continuous glucose monitoring device called Stelo, which can be used by any adult who doesn't take insulin. The launch of Stelo means that many wearable device users, such as Oura customers, will have access to Dexcom technology for the first time.
“This powerful combination (with Oura) will attract new joint customers who want to better understand the relationship 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 monitoring devices to help users eat healthier and lose weight.
Oura CEO Tom Hill described metabolic health as “the next natural dimension to the Oura Ring experience,” in a blog post after the September announcement. The company's acquisition of Veri has been completed, the spokesperson said.
Read CNBC's review of the Oura Ring 4 here. Read CNBC's review of Dexcom's Stelo here.
Feel free to send any tips, suggestions, story ideas and pitches to Ashley at ashley.capoot@nbcuni.com.
