Continuation of Phase 2/3 LIFT-AD Clinical Study for Fosgonimeton to Treat Individuals with Alzheimer Disease
The phase 2/3 LIFT-AD study (NCT04488419) for fosgonimeton (ATH-1017; Athira Pharma, Bothell, WA) to treat individuals with mild-to-moderate Alzheimer disease (AD) will continue after an unblinded interim efficacy and futility analysis. There will be an additional enrollment of fewer than 150 participants for a total enrollment of less than 300 participants without background therapy (acetylcholinesterase inhibitors). The researchers in the LIFT-AD study will observe measurements from the Global Statistical Test, the Alzheimer Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) and Alzheimer Disease Cooperative Study-Activities of Daily Living (ADCS-ADL23).
Results from the exploratory ACT-AD phase 2 study showed potential on measures of cognition (ADAS-Cog11), function (ADCS-ADL23) and neurodegeneration (plasma neurofilament light chain [NfL]) in participants receiving fosgonimeton without background therapy.
“The results from the data monitoring committee’s unblinded analysis give us confidence in a potentially positive outcome for LIFT-AD, as stringent evaluation criteria were applied based on validated and clinically meaningful cognitive and functional outcomes,” said Hans Moebius, MD, PhD, chief medical officer of Athira. “This analysis supports the potential clinical benefits of fosgonimeton treatment and underscores the rationale for continued development of this promising new therapy.”
“We are very excited by the results of this independent review as we believe they mitigate the risk of the fosgonimeton development plan, support the potential clinical benefit of fosgonimeton and inform the sample size needed to achieve success with LIFT-AD,” said Mark Litton, PhD, president and chief executive officer of Athira. “We are now targeting to complete enrollment in mid-2023 and report topline data in early 2024. Importantly, we have a strong balance sheet to execute our plans through key data readouts and beyond. Moving forward, we remain keenly focused on advancing this novel investigational therapy with the hope of positively impacting the lives of millions of AD patients.”
The unblinded interim analysis had approximately 100 participants without a background therapy to corroborate observations from the ACT-AD study. This confirmed the LIFT-AD study is able to determine the effect of fosgonimeton.