Enrollment Completed for Phase 2/3 LIFT-AD Trial Assessing Investigational Drug Targeting Neurotrophic Signaling System as Treatment for Alzheimer Disease

Athira Pharma has announced the completion of enrollment for the phase 2/3 LIFT-AD clinical trial (NCT04488419) assessing the safety and efficacy of fosgonimeton (ATH-1017; Athira Pharma, Bothell, WA) as a treatment for mild-to-moderate Alzheimer disease (AD). Fosgonimeton is an investigational small molecule designed to modulate the hepatocyte growth factor (HGF)/MET system—an important neurotrophic signaling system.

The LIFT-AD clinical trial is a randomized, double-blind, placebo-controlled trial evaluating once-daily subcutaneous injections of fosgonimeton 40 mg compared to placebo. In all, 315 treatment-free participants aged 55 to 85 years with mild-to-moderate AD have been enrolled in the study. The primary outcome measure of the study is Global Statistical Test (GST) score at 26 weeks, which is a composite of the Alzheimer’s Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) and Alzheimer’s Disease Cooperative Study-Activities of Daily Living 23-item version (ADCS-ADL23) scores, which also will be assessed separately as secondary outcome measures. Additionally, changes in neurofilament light chain (NfL) concentration will be assessed at week 26 as a secondary outcome measure as a biomarker for neurodegeneration.

“The successful completion of enrollment in LIFT-AD marks an important milestone for Athira and enables the topline data readout in the second half of 2024,” said Mark Litton, PhD, President and CEO of Athira. “We believe LIFT-AD has the potential to meet the study’s primary endpoint based on the unblinded interim efficacy and futility analysis performed by an independent committee on the first 100 patients who completed the trial.”