Azheimer’s LIFT-AD trial of fosgonimeton is recommended to continue by monitoring committee
A Phase II/III clinical trial evaluating Athira Pharma’s experimental therapy fosgonimeton (formerly ATH-1017) in people with mild to moderate Alzheimer’s disease should continue as planned
That is the recommendation of an independent data monitoring committee following an interim analysis on 100 participants not on standard acetylcholinesterase (AChE) inhibitors to assess whether fosgonimeton was indicating superior effectiveness over a placebo, as well as favorable safety.
AChE inhibitors approved for Alzheimer’s include Aricept (donepezil), Exelon (rivastigmine), and Razadyne (galantamine). The analysis also allowed the committee to establish that adding up to 150 patients not taking AChE inhibitors — for up to a total of 300 people — would be enough to power the trial to assess its primary goal.
The trial, called LIFT-AD (NCT04488419), is recruiting patients, ages 55 to 85, who are not on AChE inhibitors at more than 40 U.S. sites. Athira anticipates completing its target enrollment by the middle of next year and expects top-line data in early 2024.
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