Eli Lilly announced on Wednesday that it will discontinue the development of its Alzheimer’s treatment candidate solanezumab after the antibody failed to slow disease progression.
Solanezumab’s lack of efficacy deals a setback to efforts aimed at treating Alzheimer’s disease in individuals who are in its earliest stages and have not yet displayed clinical symptoms.
The study included over 1,000 elderly participants who exhibited normal memory and cognitive function but showed indications of brain plaque associated with Alzheimer’s disease.
Solanezumab did not succeed in clearing or halting the accumulation of amyloid plaque in the brain fluid, nor did it slow cognitive decline among those who received the treatment.
“These data suggest that we may need to adopt a more aggressive approach to amyloid removal even at this very early disease stage,” said Dr. Reisa Sperling, a neurologist at Brigham and Women’s Hospital and the study’s director.
Solanezumab was designed to target amyloid proteins present in brain fluid before they deposit as plaque on the brain.
Lilly is concurrently developing two other Alzheimer’s treatments, donanemab and remternetug, both of which are in late-stage clinical trials.
These antibodies focus on amyloid plaque already deposited on the brain and aim to treat individuals experiencing early symptoms of the disease.
Lilly anticipates releasing clinical trial data on donanemab in the second quarter of this year and plans to seek FDA approval for the treatment if the results are positive.
Earlier this year, Lilly requested expedited approval of donanemab from the FDA, which was declined in January.
The agency stipulated that Lilly must submit data on at least 100 patients who received the treatment for a duration of 12 months.
Dr. Dan Skovronsky, Lilly’s chief scientific officer, explained during the company’s earnings call in February, “Due to the rapid reduction of plaque observed, many patients were able to discontinue treatment as early as six months, resulting in fewer patients receiving 12 months or more of dosing.”
“We remain optimistic about the potential of donanemab as a new treatment for individuals with early symptomatic Alzheimer’s disease,” Skovronsky affirmed.
In January, the FDA granted expedited approval to Eisai’s and Biogen’s early Alzheimer’s treatment, Leqembi. The companies anticipate a decision on full approval from the FDA by July.
Medicare currently covers Alzheimer’s antibody drugs approved via expedited pathways for individuals participating in clinical trials. The program intends to broaden coverage once the FDA grants full approval.
Clarification: Solanezumab was designed to target amyloid proteins present in brain fluid before they deposit as plaque on the brain.
