In another blow to Alzheimer’s treatment efforts in people in the very early stage of the disease, Eli Lilly has halted development of its treatment solanezumab after the antibody failed to slow disease progression.
The study had enrolled more than 1 000 seniors with normal memory and thinking function, but who showed signs of brain plaque associated with Alzheimer’s. Disappointingly, however, solanezumab did not clear or halt accumulation of the plaque, called amyloid, which floats on the brain, and did not slow cognitive decline.
“These data suggest we may need to 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.
Lilly is developing two other Alzheimer’s treatments that are in late-stage clinical trials, donanemab and remternetug, also targeting plaque on the brain and which are designed to treat people with early symptoms of the disease, reports CNBC.
Lilly is expecting to publish clinical trial data on donanemab in the second quarter of this year and plans to ask the US Food and Drug Administration to approve the treatment if those data are positive.
Lilly had asked the FDA for expedited approval of donanemab but the agency rejected the company’s request in January, saying it needed data on at least 100 patients who had received the treatment for 12 months.
Lilly said it did not have that data because donanemab cleared brain plaque quickly in many patients.
“Due to the speed of plaque reduction we saw, many patients were able to stop dosing as early as six months into treatment, resulting in fewer patients receiving 12 months or more of donanemab dosing,” said Dr Dan Skovronsky, Lilly’s chief scientific officer in February.
The FDA approved Eisai’s and Biogen’s early Alzheimer’s treatment Leqembi on an expedited basis in January. The companies expect the agency to make a decision on full approval in July.
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