Eli Lilly treatment with solanezumab failed to slow the disease

The Eli Lilly logo is displayed at one of the company’s offices in San Diego, California September 17, 2020.

Mike Blake | Reuters

Eli Lilly said Wednesday it will halt development of its Alzheimer’s treatment candidate, solanezumab, after the antibody failed to slow disease progression.

Solanezumab’s failure is a blow to efforts to treat Alzheimer’s disease in people who are in the very early stages of the disease and have not yet shown clinical signs.

The study included more than 1,000 seniors 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 the plaque called amyloid and did not slow cognitive decline in the 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, a neurologist at Brigham and Women’s Hospital and the director of the study.

Solanezumab is designed to target plaque floating in the brain. Lilly is developing two other Alzheimer’s treatments that are in late-stage clinical trials, donanemab and remternetug. These antibodies target plaque that has deposited on the brain and are designed to treat people who have early symptoms of the disease.

Lilly expects to publish 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 that data is positive.

Lilly had asked the FDA for accelerated approval of donanemab, but the agency denied the company’s request in January. The agency told Lilly it must submit data from at least 100 patients who received the treatment over 12 months.

Lilly said it didn’t have that data because donanemab cleared brain plaque quickly in many patients.

“The rate of plaque reduction that we saw allowed many patients to stop dosing as early as six months into treatment, resulting in fewer patients receiving donanemab dosing for 12 months or more,” Dr. Dan Skovronsky, Lilly’s chief of scientific research, told analysts on the company’s earnings call in February.

“We remain confident in the potential new treatment of donanemab for people with early-stage Alzheimer’s disease,” Skovronsky said.

The FDA fast-tracked approval of Eisai and Biogen’s early Alzheimer’s treatment, Leqembi, in January. The companies expect the agency to make a decision on full approval in July.

Medicare only covers Alzheimer’s antibody drugs that receive accelerated approval for people participating in clinical trials. The public health insurance program for seniors said it will provide broader coverage once the FDA grants full approval.