Athira Pharma Completes Enrollment of Phase 2/3 LIFT-AD Clinical Trial of Fosgonimeton in Mild-to-Moderate Alzheimer’s Disease

Athira Pharma, Inc. recently announced completion of enrollment in the Phase 2/3 LIFT-AD clinical trial of fosgonimeton as a potential treatment for mild-to-moderate Alzheimer’s disease. Fosgonimeton is a potentially first-in-class, investigational, small molecule designed to positively modulate the hepatocyte growth factor (HGF) system, which can activate neuroprotective, neurotrophic, and anti-inflammatory pathways in the central nervous system.

“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 Chief Executive Officer 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. This interim analysis gives 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. We are also encouraged that more than 85% of participants who completed the LIFT-AD and ACT-AD clinical trials elected to participate in the open label extension trial (OLEX). Notably, there are currently more than 60 patients in this open label trial who are continuing fosgonimeton treatment beyond 18 months, which is unexpected in a progressive mild-to-moderate Alzheimer’s disease population. We also recently reported findings from the exploratory SHAPE Phase 2 clinical trial, which investigated the use of fosgonimeton in patients with Parkinson’s disease dementia and dementia with Lewy Bodies. The results showed positive effects on several cognitive measures in the fosgonimeton 40 mg dose group, which is the same dose being investigated in the LIFT-AD trial. Collectively, the extended duration of OLEX participation and the SHAPE findings add to our confidence for a positive LIFT-AD outcome and support the potential of our HGF modulation franchise in neurodegeneration.”

The Phase 2/3 LIFT-AD clinical trial, which targeted an enrollment of 298 patients in the primary analysis population, ultimately enrolled approximately 315 patients with mild-to-moderate Alzheimer’s disease in a 26-week, randomized, double-blind, placebo-controlled clinical trial evaluating once-daily subcutaneous injections of fosgonimeton 40 mg compared to placebo. The primary endpoint is the Global Statistical Test (GST), a composite of the co-key secondary endpoints ADAS-Cog11 and ADCS-ADL23. Key secondary and exploratory endpoints include changes in plasma biomarkers of neurodegeneration, protein pathology, and neuroinflammation. Additional information about the LIFT-AD study can be found at: NCT04488419.

Athira Pharma, Inc., headquartered in the Seattle, WA, area, is a late clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and slow neurodegeneration. Athira aims to alter the course of neurological disease by advancing its pipeline of therapeutic candidates targeting the neurotrophic HGF system for Alzheimer’s and Parkinson’s disease, Dementia with Lewy bodies, and amyotrophic lateral sclerosis. For more information, visit www.athira.com.