Athira Pharma completes patient dosing in Phase 2/3 trial of fosgonimeton in AD

Athira Pharma, Inc. (NASDAQ: ATHA), a prominent biopharmaceutical company specializing in neurodegenerative diseases, has announced the completion of patient dosing in the Phase 2/3 LIFT-AD clinical trial. This trial is pivotal in evaluating fosgonimeton, a novel treatment for individuals with mild-to-moderate Alzheimer’s disease (AD). Athira is set to unveil topline results by the end of the third quarter of 2024 and will present detailed findings at the 17th Clinical Trials on Alzheimer’s Disease (CTAD) conference in Madrid, Spain.

Located in Seattle, Washington, Athira Pharma focuses on developing small molecules aimed at restoring neuronal health and slowing neurodegeneration. The LIFT-AD trial, a randomized, placebo-controlled, double-blind study, involved approximately 315 patients who were not on acetylcholinesterase inhibitors. Participants received daily subcutaneous injections of 40 mg fosgonimeton or a placebo for a 26-week period. The primary measure of the trial’s success, the Global Statistical Test (GST), combines results from cognitive and functional assessments, specifically ADAS-Cog11 and ADCS-ADL23, which are recognized by the U.S. Food and Drug Administration.

Dr. Javier San Martin, Chief Medical Officer at Athira, emphasized the comprehensive nature of the GST, which assesses cognition and function, the core areas affected by Alzheimer’s disease. The trial also measured serum biomarkers to explore the neuroprotective and disease-modifying effects of fosgonimeton.

Significantly, 85% of participants from the LIFT-AD and the earlier Phase 2 ACT-AD trial chose to continue in Athira’s open label extension study (OLEX), indicating strong patient commitment and belief in the potential of fosgonimeton. This ongoing study allows participants to continue or start treatment with fosgonimeton, with many extending their participation beyond 18 months, showcasing the drug’s potential for long-term efficacy.

Mark Litton, Ph.D., President and CEO of Athira, expressed optimism about the upcoming data readout, highlighting fosgonimeton’s innovative approach to activating neuroprotective, neurotrophic, and anti-inflammatory pathways in the central nervous system. Fosgonimeton, a potentially first-in-class therapy, is also being considered for other neurodegenerative diseases such as Parkinson’s disease and dementia with Lewy bodies.

Athira recently hosted a Key Opinion Leader event to discuss the GST and its implications for Alzheimer’s treatment. The event featured insights from Suzanne Hendrix, Ph.D., CEO of Pentara Corporation, and Anton P. Porsteinsson, M.D., Director of the AD-CARE program at the University of Rochester, reinforcing the drug’s promising profile.

As Athira prepares to share the LIFT-AD results, the medical community and patients alike eagerly anticipate a potential breakthrough in Alzheimer’s treatment that could significantly alter the course of managing the disease.