Athira Pharma Finishes Patient Recruitment for LIFT-AD Trial on Alzheimer’s Drug

Athira Pharma, a late-stage biopharmaceutical firm, has completed enrollment for its Phase 2/3 LIFT-AD clinical trial. The trial is evaluating fosgonimeton, an experimental small molecule, as a potential treatment for Alzheimer's disease. The drug is designed to modulate the hepatocyte growth factor (HGF) system, which can activate neuroprotective, neurotrophic, and anti-inflammatory pathways in the central nervous system.

Mark Litton, Athira's President and CEO, highlighted the significance of the enrollment completion and the potential for fosgonimeton to meet the study's primary endpoint. The interim analysis of the first 100 patients who completed the trial was conducted by an independent committee and supports the continuation of the trial. More than 85% of participants who completed the LIFT-AD and ACT-AD trials chose to continue in the open label extension trial (OLEX). Currently, over 60 patients have been on fosgonimeton treatment for more than 18 months, which is a positive sign for a progressive mild-to-moderate Alzheimer's disease population.

Additionally, the SHAPE Phase 2 clinical trial results showed positive effects on cognitive measures for the fosgonimeton 40 mg dose group, the same dosage being studied in LIFT-AD. The Phase 2/3 LIFT-AD trial enrolled approximately 315 patients with mild-to-moderate Alzheimer's disease. The trial is a 26-week, randomized, double-blind, placebo-controlled study comparing once-daily subcutaneous injections of fosgonimeton 40 mg to a placebo. The primary endpoint is the Global Statistical Test (GST), a composite of the co-key secondary endpoints ADAS-Cog11 and ADCS-ADL23. Secondary and exploratory endpoints include changes in plasma biomarkers of neurodegeneration, protein pathology, and neuroinflammation.

Athira Pharma is headquartered in Seattle, Washington, and is focused on developing small molecules to restore neuronal health and slow neurodegeneration. The company's pipeline includes therapeutic candidates targeting the neurotrophic HGF system for various neurological diseases, including Alzheimer's and Parkinson's disease, Dementia with Lewy bodies, and amyotrophic lateral sclerosis.