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Analysts suggest that Eli Lilly may have a potential blockbuster drug in the making: an experimental pill aimed at reducing an inherited form of high cholesterol.
The pharmaceutical company unveiled mid-stage trial data on the pill, muvalaplin, at the American Heart Association Scientific Sessions meeting in Chicago. This development showcases the breadth of Eli Lilly’s drug pipeline beyond its leading weight loss and diabetes treatments.
Muvalaplin stands out as the sole oral treatment among various injectable therapies in progress to address high levels of lipoprotein(a) – or Lp(a) – in the blood, a hereditary risk factor for heart disease. This includes Eli Lilly’s late-stage injectable drug, lepodisiran, as well as injections from Novartis and Amgen.
Approximately one in five Americans, or 63 million individuals, have elevated Lp(a) levels, according to the Family Heart Foundation.
Currently, there are no approved treatments to lower Lp(a), which can significantly elevate the risk of heart attack, stroke, and arterial plaque buildup. Unlike low-density lipoprotein (LDL) or “bad cholesterol,” which can be managed with lifestyle changes and statins, Lp(a) levels are genetically determined and remain unaffected by diet or exercise, as stated by Ruth Gimeno, Lilly’s group vice president for diabetes and metabolic research.
The phase two trial evaluated three daily doses of the pill – 10, 60, and 240 milligrams – against a placebo over 12 weeks in adults with high cardiovascular risk due to very high Lp(a) levels. Eli Lilly researchers utilized both a traditional blood test and a new company-developed method to measure intact Lp(a) particles in the blood.
The highest dose of the pill reduced Lp(a) levels by 70% compared to the placebo based on the traditional blood test and nearly 86% relative to the placebo based on the more specific test. The 60-milligram dose similarly decreased levels by 81.7% compared to the placebo based on the more specific test, while the 10-milligram dose lowered them by 47.6%.
In terms of safety, side effects were comparable between those receiving Eli Lilly’s drug and the placebo group.
Eli Lilly is in discussions with the FDA regarding the next steps for the drug, including designing a phase three trial. The company estimates that it may take “four or five years until we see the final results” from a late-stage study, according to Gimeno.
Late-stage trials will likely determine whether the pill can reduce cardiovascular events such as heart attacks and strokes.
In a research note, Leerink Partners analyst David Risinger mentioned that Eli Lilly’s pill seems competitive with injectable therapies based on the phase two trial data. Risinger added that muvalaplin could have “megablockbuster potential” if late-stage data demonstrates its ability to prevent outcomes like heart attacks and strokes proactively.
He noted that Novartis’ experimental injection, pelacarsen, might be the first treatment to exhibit the benefits of lowering Lp(a) levels in reducing cardiovascular risks. Novartis is expected to release data from a late-stage trial on the injection in mid-2025.
Dexcom announced on Tuesday that its glucose biosensors will integrate with Oura’s smart rings as part of a new collaboration. Dexcom also initiated Oura’s latest funding round by investing $75 million, valuing the company at over $5 billion.
Additional investors in the round have yet to be determined, according to an Oura spokesperson.
Oura’s rings monitor sleep, exercise, stress, heart health, and other metrics. The company recently launched new hardware and an updated app. Dexcom’s continuous glucose monitors are small sensors that penetrate the skin to measure real-time blood sugar levels.
Through this partnership, data will flow between Dexcom and Oura products, enabling users to access a more comprehensive view of their health. The first app integration between the two companies is set to launch in the first half of next year.
Oura and Dexcom will also engage in cross-selling and co-marketing their products.
Dexcom’s devices have traditionally targeted diabetes patients but have expanded into more consumer-friendly markets this year. In August, the company introduced a new over-the-counter continuous glucose monitor called Stelo, suitable for adults not taking insulin. This launch allows wearable users like Oura customers to 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,” said Matt Dolan, Dexcom’s executive vice president of strategy and corporate development.
Oura paved the way for its collaboration with Dexcom by expressing interest in the metabolic health sector this year. In September, Oura announced its acquisition of Veri, a company utilizing continuous glucose monitors to assist users in eating healthier and losing weight.
Oura CEO Tom Hale described metabolic health as the “natural next dimension of the Oura Ring experience” in a blog post following the September announcement. The acquisition of Veri has been finalized, as per the spokesperson.
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