Happy Tuesday! 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 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.
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