The Eli Lilly logo is displayed on one of the company’s offices in San Diego, California, September 17, 2020.
Mike Blake | Reuters
Eli Lilly announced on Wednesday that it would halt development of its Alzheimer’s disease treatment candidate solanezumab after the antibody failed to slow disease progression.
The failure of solanezumab is a blow to efforts to treat Alzheimer’s disease in people who are in the very early stages of the disease and who have not yet shown clinical symptoms.
The study recruited more than 1,000 elderly people who had normal memory and thinking function but showed signs of brain plaque associated with Alzheimer’s disease.
Solanezumab did not remove or stop the buildup of plaque, called amyloid, and did not slow cognitive decline in participants who received the treatment.
“These data suggest that we may need to be more aggressive with amyloid removal, even at this very early stage of the disease,” said Dr. Reisa Sperling, neurologist at Brigham and Women’s Hospital and director of the ‘study.
Solanezumab was designed to target floating plaque in the brain. Lilly is developing two other treatments for Alzheimer’s disease that are in late-stage clinical trials, donanemab and remternetug. These antibodies target the plaque that has deposited on the brain and are designed to treat people who show the first symptoms of the disease.
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Lilly expects to release clinical trial data on donanemab in the second quarter of this year. The company plans to ask the Food and Drug Administration to approve the treatment if this data is positive.
Lilly had asked the FDA for expedited approval of donanemab, but the agency denied the company’s request in January. The agency told Lilly it must submit data on at least 100 patients who received the treatment for 12 months.
Lilly said it does not have these data because donanemab rapidly cleared brain plaque in many patients.
“Because of the rate of plaque reduction we saw, many patients were able to stop treatment as early as six months of treatment, which reduced the number of patients receiving 12 months or more of donanemab dosing,” said said Dr. Dan Skovronsky, scientific director of Lilly. , told analysts during the company’s February earnings call.
“We remain confident in the potential of donanemab as a new treatment for people with early symptomatic Alzheimer’s disease,” Skovronsky said.
The FDA approved Eisai and Biogen’s early Alzheimer’s disease treatment, Leqembi, on an accelerated basis in January. The companies expect the agency to make a decision on full approval in July.
Medicare will only cover Alzheimer’s antibody drugs that receive fast-track approval for people in clinical trials. The public health insurance program for seniors said it would provide broader coverage as soon as the FDA grants full approval.