Athira Pharma, Inc. announced the completion of dosing for the last patient in the Phase 2/3 LIFT-AD clinical trial evaluating fosgonimeton in people with mild-to-moderate Alzheimer?s disease (AD). The Company is now targeting to report topline results from the LIFT-AD trial by the end of the third quarter of 2024 and has been invited to discuss the fuller data set during an oral presentation on October 29, 2024, at the 17th Clinical Trials on Alzheimer?s Disease (CTAD) conference taking place from October 29 ? November 1, 2024, in Madrid, Spain.

LIFT-AD (NCT04488419) is a randomized, placebo-controlled, double-blind study evaluating the efficacy and safety of fosgonimeton, which is designed to positively modulate the neurotrophic hepatocyte growth factor (HGF) system to protect and preserve neuronal health and function. The trial enrolled approximately 315 patients not on acetylcholinesterase inhibitors (AChEIs) with mild-to-moderate AD to evaluate once-daily subcutaneous injections of fosgonimeton 40 mg compared to placebo over a 26-week treatment period. The primary endpoint of LIFT-AD is the change from baseline after 26 weeks of treatment using the Global Statistical Test (GST), a combination of results from measures of cognition (ADAS-Cog11) and function (ADCS-ADL23).

Notably, 85% of eligible clinical trial participants in LIFT-AD and the Phase 2 ACT-AD trial elected to enroll in Athira?s open label extension study (OLEX), which enables participants to either remain on fosgonimeton or, for those in the placebo group, begin fosgonimeton treatment. Currently, more than 70 patients are continuing fosgonimeton treatment beyond 18 months, with nearly 50 patients beyond two years, reflecting a long-term participation rate beyond what might be expected in a progressive mild-to-moderate Alzheimer?s disease population. Athira management recently hosted a Key Opinion Leader event focusing on GST, the primary endpoint of the LIFT-AD clinical trial, which Athira believes is a comprehensive measure of overall disease impact and the potential for fosgonimeton to protect and preserve neuronal health in mild-to-moderate AD patients.

The webcast event featured presentations from Suzanne Hendrix, Ph.D., Founder and CEO of Pentara Corporation, and Anton P. Porsteinsson, M.D., Director of the University of Rochester Alzheimer?s Disease Care, Research, and Education Program (AD-CARE).