Medical bottles and syringes with the logo of Eli Lilly and Company are seen on a screen in the background in this illustrative photo taken in Krakow, Poland, on November 10, 2022.
Jakub Porzycki | Nurphoto | Getty Images
Eli LilliThe company’s investigational Alzheimer’s drug reduced levels of brain plaque in patients who are in the earliest stages of the devastating disease, early data show.
A higher dose of the emerging drug Remternetug had a greater effect on clearing amyloid plaque, according to initial clinical trial data the company presented at a conference in Sweden on Friday.
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Amyloid is a protein that accumulates in the brains of Alzheimer’s patients and disrupts cell function. Researchers have argued that amyloid plaque buildup is a critical first step toward the cognitive decline seen in Alzheimer’s disease.
The first data comes as Eli Lilly continues its decades-long quest to bring an Alzheimer’s drug to market. Remternetug follows a drug called donanemab and an unsuccessful treatment with solanezumab. Remternetug and donanemab target plaque that builds up in the brain, while solanezumab focuses on the type that swims in the brain fluid.
The Remternetug study enrolled 41 patients with early-stage Alzheimer’s disease. They were randomized to receive infusions of placebo or Remternetug in varying doses every four weeks.
Eli Lilly found the drug caused “rapid and robust” amyloid plaque clearance, the presentation said. Clearing amyloid plaque is defined as bringing the level down to 24.1 centiloids — a unit used to measure amyloid in the brain — or less.
Plaque levels are “dose dependent,” the company says. In the majority of patients who received Remternetug at the three highest dose levels, amyloid plaque had disappeared by day 169 of the study.
The Indianapolis-based company is conducting an ongoing Phase 3 study of Remternetug, but did not specify what dose sizes it is studying. Eli Lilly expects to complete the process in 2025.
The results suggest that Remternetug “might provide more robust plaque removal” than donanemab, said JK Wall, a spokeswoman for Eli Lilly.
A phase 2 study of donanemab found that 40% of participants were treated with the drug amyloid clearance is achieved as early as six months, or approximately 182 days, after starting treatment.
But Wall added that it’s still too early to make quantitative comparisons of the two drugs.
Akash Tewari, an equity analyst at Jefferies, also highlighted “evidence of faster amyloid clearance with Remternetug vs. donanemab” in a Friday note. However, Tewari said it is uncertain whether removing amyloid plaque will result in clinical benefits such as a reduction in cognitive decline.
He noted that some research has shown a causal relationship between plaque clearance and the rate of cognitive decline, but “we have not seen this confirmed by the donanemab data.”
Tewari also compared the safety profiles of the two drugs. He estimates that Remternetug may have similar or higher rates of a problematic brain swelling side effect compared to donanemab.
Eli Lilly observed the side effect — known as amyloid-related imaging abnormality, or ARIA — in 10 of 24 patients who received Remternetug. One of these patients discontinued treatment due to a serious adverse event.
ARIA has been pursuing similar Alzheimer’s drugs from other companies, such as Leqembi biogenic And Eisai. The companies expect the Food and Drug Administration to give Leqembi full approval by the summer.
According to the Alzheimer’s Association, an estimated 6.7 million Americans age 65 and older are living with Alzheimer’s. By 2050, this group is expected to grow to nearly 13 million.
One in three seniors will die of Alzheimer’s or another form of dementia, which kills more people than breast cancer and prostate cancer combined, the association said.
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