Athira Pharma Completes LIFT-AD Trial for Fosgonimeton in Alzheimer's

Athira Pharma, Inc., a biopharmaceutical company in the late stages of clinical development, has announced the completion of dosing for the final patient in its Phase 2/3 LIFT-AD trial. This trial investigates the efficacy and safety of fosgonimeton in individuals with mild-to-moderate Alzheimer’s disease (AD). Topline results from LIFT-AD are anticipated by the end of the third quarter of 2024. The study's more comprehensive data set will be discussed during an oral presentation at the 17th Clinical Trials on Alzheimer’s Disease (CTAD) conference on October 29, 2024, in Madrid, Spain.

The LIFT-AD trial (NCT04488419) is a randomized, placebo-controlled, double-blind study aimed at evaluating fosgonimeton, a treatment designed to modulate the neurotrophic hepatocyte growth factor (HGF) system. The objective is to protect and preserve neuronal health and function. About 315 patients not using acetylcholinesterase inhibitors (AChEIs) were enrolled to receive either daily subcutaneous injections of 40 mg of fosgonimeton or a placebo over a 26-week period. The primary endpoint is the change from baseline after 26 weeks using the Global Statistical Test (GST), which combines measures of cognition (ADAS-Cog11) and function (ADCS-ADL23).

Javier San Martin, M.D., Chief Medical Officer of Athira, expressed optimism about the trial's progress, noting the primary endpoint GST's comprehensive assessment of multiple disease aspects. GST includes two clinical assessments—ADAS-Cog11 and ADCS-ADL23—widely used in AD trials and accepted by the U.S. Food and Drug Administration and other regulatory bodies. The trial also evaluates serum biomarkers to understand fosgonimeton’s potential neuroprotective and disease-modifying effects. Dr. San Martin thanked the investigators, staff, patients, and caregivers for their participation in LIFT-AD.

The LIFT-AD trial and the Phase 2 ACT-AD trial saw 85% of eligible participants join Athira's open-label extension study (OLEX). In OLEX, participants continue with fosgonimeton treatment, including those initially in the placebo group. Over 70 patients have been on fosgonimeton for more than 18 months, with nearly 50 exceeding two years, demonstrating robust long-term participation.

Mark Litton, Ph.D., President and CEO of Athira, highlighted the significant milestone achieved in the LIFT-AD trial and looked forward to the forthcoming data readout. Dr. Litton emphasized the need for improved therapies for Alzheimer’s disease and expressed hope that fosgonimeton’s unique mechanism, acting on the neurotrophic HGF system, could offer a first-in-class therapeutic option, potentially altering Alzheimer’s disease progression by activating neuroprotective, neurotrophic, and anti-inflammatory pathways in the central nervous system.

Athira recently hosted an event focusing on GST, the primary endpoint of the LIFT-AD trial. Presentations were given by 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), highlighting the comprehensive measure of disease impact provided by GST and fosgonimeton’s potential in protecting neuronal health in mild-to-moderate AD patients.

Fosgonimeton is a promising, once-daily subcutaneously administered small molecule drug candidate. It aims to protect and repair neuronal networks, showing potential to address a wide range of neurodegenerative diseases, including Alzheimer’s, Parkinson’s disease, and dementia with Lewy bodies.

Athira Pharma, Inc., headquartered near Seattle, Washington, is dedicated to developing small molecules to restore neuronal health and slow neurodegeneration. Athira strives to change the course of neurological diseases by advancing its pipeline of therapeutic candidates that modulate the HGF system, including fosgonimeton, which is being evaluated for mild-to-moderate Alzheimer’s disease in the LIFT-AD trial expected to report topline data by the end of the third quarter of 2024.