Eli Lilly on Wednesday said it should halt development of its Alzheimer’s treatment candidate solanezumab after the antibody didn’t slow disease progression.
Solanezumab’s failure is a blow to efforts to treat Alzheimer’s in people who find themselves within the very early stage of the disease and haven’t yet shown clinical symptoms.
The study enrolled greater than 1,000 seniors who had normal memory and considering function, but showed signs of brain plaque that’s related to Alzheimer’s.
Solanezumab didn’t clear or halt accumulation of the plaque, called amyloid, and didn’t slow cognitive decline within the participants who received the treatment.
“These data suggest that we may must be more aggressive with amyloid removal even at this very early stage of disease,” said Dr. Reisa Sperling, a neurologist at Brigham and Women’s Hospital and the director of the study.
Solanezumab was designed to focus on plaque that floats within the brain. Lilly is developing two other Alzheimer’s treatments which might be in late-stage clinical trials, donanemab and remternetug. These antibodies goal plaque that has deposited on the brain and are designed to treat individuals who have early symptoms of the disease.
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Lilly is expecting to publish clinical trial data on donanemab within the second quarter of this yr. The corporate plans to ask the Food and Drug Administration to approve the treatment if that data is positive.
Lilly had asked the FDA for expedited approval of donanemab however the agency rejected the corporate’s request in January. The agency told Lilly that it must submit data on no less than 100 patients who received the treatment for 12 months.
Lilly said it didn’t have that data because donanemab cleared brain plaque quickly in lots of patients.
“As a consequence of the speed of plaque reduction that we saw, many patients were capable of stop dosing as early as six months into treatment, leading to fewer patients receiving 12 months or more of donanemab dosing,” Dr. Dan Skovronsky, Lilly’s chief scientific officer, told analysts throughout the company’s earnings call in February.
“We remain confident within the of potential donanemab as a latest treatment for individuals with early symptomatic Alzheimer’s disease,” Skovronsky said.
The FDA approved Eisai’s and Biogen’s early Alzheimer’s treatment Leqembi on an expedited basis in January. The businesses expect the agency to make a choice on full approval in July.
Medicare will only cover Alzheimer’s antibody drugs that receive expedited approval for people participating in clinical trials. The general public medical health insurance program for seniors said it should provide broader coverage as soon because the FDA grants full approval.
