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Analysts say Eli Lilly may have a future blockbuster drug on its hands: An experimental pill designed to lower an inherited form of high cholesterol.
The pharmaceutical giant presented mid-stage trial data on the pill, muvalaplin, at the American Heart Association Scientific Sessions meeting in Chicago on Monday. The treatment demonstrates the diversity of Eli Lilly’s drug pipeline beyond its top-selling weight loss and diabetes treatments.
Here’s 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, an inherited risk factor for heart disease. That includes Eli Lilly’s own late-stage injectable drug, lepodisiran, and injections from 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 a buildup 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, Ruth Gimeno, Lilly’s group vice president for diabetes and metabolic research, said in an interview.
That is unlike 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 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 highest dose of the pill decreased Lp(a) levels by 70% compared to the placebo based on the traditional blood test, and almost 86% relative to the placebo based on the more specific test, according to the results.
The 60-milligram dose similarly reduced levels by 81.7% compared to the placebo based on the more specific test, while the 10-milligram dose decreased them by 47.6%.
In terms of safety, side effects were similar among 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 flags at all.”
She said 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.
She 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 the phase two trial data.
Risinger added that muvalaplin has “megablockbuster potential” if late-stage data shows that it can help prevent outcomes like heart attacks and strokes before they occur.
He noted that Novartis’ experimental injection, pelacarsen, could be the first treatment to show the benefits of lowering Lp(a) levels in reducing cardiovascular risks. The company is slated to release data from a late-stage trial on the injection in mid-2025.
Feel free to send any tips, suggestions, story ideas and data to Annika at annikakim.constantino@nbcuni.com.
Latest in health-care tech: Dexcom invests $75 million in Oura, companies ink new partnership
The Dexcom logo is seen on a smartphone screen and in the background.
Dexcom on Tuesday announced its glucose biosensors will be compatible with Oura’s smart rings as part of a new integration. Dexcom also kicked off Oura’s latest funding round by investing $75 million, which values the company at more than $5 billion, according to a release.
Additional investors in the round have not been determined, an Oura spokesperson told CNBC.
Oura’s rings track sleep, exercise, stress, heart health and other metrics. The company launched new hardware and a refreshed app last month. Dexcom’s continuous glucose monitors are small sensors that poke through the skin to measure real-time blood sugar levels.
Through the new partnership, data will flow between Dexcom and Oura products so that 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 release said.
Dexcom’s devices have historically been designed for patients with diabetes, but it has started to push into more consumer-friendly markets this year. The company in August released a new over-the-counter continuous glucose monitor called Stelo, which can be used by any adults who do not take insulin. The launch of Stelo means many wearable users, like 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, Dexcom’s executive vice president of strategy and corporate development, 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 has 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 “natural next 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 the Oura Ring 4 here. Read CNBC’s review of Dexcom’s Stelo here.
Feel free to send any tips, suggestions, story ideas and data to Ashley at ashley.capoot@nbcuni.com.