Eli Lilli on Wednesday said it would halt development of its Alzheimer’s treatment candidate solanezumab after the antibody failed to slow the progression of the disease.
The failure of solanezumab is a setback to efforts to treat Alzheimer’s disease in people who are very early in the disease and have not yet presented clinical symptoms.
The study involved more than 1,000 seniors who had normal memory and thinking function but showed signs of brain plaque associated with Alzheimer’s.
Solanezumab did not clear or stop the buildup of the plaque called amyloid or slow cognitive decline in the participants who received the treatment.
“These data suggest that we may need to be more aggressive in removing amyloid even at this very early stage of the disease,” said Dr. Reisa Sperling, neurologist at Brigham and Women’s Hospital and leader of the study.
Solanezumab was designed to attack amyloid protein that swims in the brain fluid. Lilly is developing two other Alzheimer’s treatments that are in late-stage clinical trials, donanemab and Remternetug. These antibodies target amyloid plaques that have built up in the brain and were designed to treat people with early symptoms of the disease.
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Lilly expects to release clinical trial data for donanemab in the second quarter of this year. The company plans to ask the Food and Drug Administration to approve the treatment if those data are positive.
Lilly had asked the FDA for an accelerated approval of donanemab, but the agency denied the company’s application in January. The agency told Lilly that it must provide data from at least 100 patients who received the treatment for 12 months.
Lilly said it didn’t have that data because donanemab quickly cleared brain plaques in many patients.
“Because of the speed of plaque reduction that we observed, many patients were able to stop taking donanemab as early as six months of treatment, resulting in fewer patients receiving donanemab dosing for 12 months or more,” said Dr. Dan Skovronsky, Lilly’s chief scientific officer, told analysts during the company’s earnings call in February.
“We remain hopeful that donanemab may be a new treatment for people with early symptomatic Alzheimer’s disease,” said Skovronsky.
The FDA approved Eisai’s and Biogen’s early Alzheimer’s drug Leqembi on an accelerated basis 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 offer broader coverage once the FDA grants full approval.
Clarification: Solanezumab was designed to attack amyloid protein, which swims in the brain fluid before it builds up as plaque in the brain.
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