Fosgonimeton Phase 2/3 Trial Enrollment for Alzheimer's Complete

Athira Pharma, a biopharmaceutical firm in the Seattle area, has completed enrolling patients for the Phase 2/3 LIFT-AD clinical trial. This trial is testing fosgonimeton, a new type of small molecule, as a treatment for mild to moderate Alzheimer's disease. The drug is designed to work with the hepatocyte growth factor (HGF) system, which can trigger neuroprotective, neurotrophic, and anti-inflammatory pathways in the brain.

Fosgonimeton is a novel compound that could be the first of its kind, targeting the modulation of the HGF system. The Phase 2/3 trial aimed to enroll 298 patients but ended up with approximately 315 participants. The study is a 26-week, randomized, double-blind, placebo-controlled trial that compares daily subcutaneous injections of 40 mg fosgonimeton to a placebo. The main goal is to see if the drug can improve on cognitive and functional measures, which are key secondary endpoints.

Mark Litton, President and CEO of Athira, stated that the completion of enrollment is a significant step for the company and sets the stage for the release of the trial's primary data in late 2024. An interim analysis conducted by an independent committee on the first 100 trial participants has been encouraging, suggesting that fosgonimeton could meet the study's main objectives. This analysis was based on strict criteria related to validated cognitive and functional outcomes.

Furthermore, over 85% of individuals who finished the LIFT-AD and ACT-AD trials chose to continue in an open label extension trial (OLEX). Currently, more than 60 patients in the OLEX have been on fosgonimeton for over 18 months, which is quite remarkable given the progressive nature of mild to moderate Alzheimer's disease. Athira also reported positive findings from the SHAPE Phase 2 trial, which looked into fosgonimeton's effects on patients with Parkinson’s disease dementia and dementia with Lewy Bodies. The results indicated beneficial impacts on several cognitive measures, particularly in the group receiving the 40 mg dose, which is identical to the dosage in the LIFT-AD trial.

Athira Pharma is dedicated to developing small molecules that can restore neuronal health and slow the progression of neurodegenerative diseases. Their pipeline includes candidates that target the neurotrophic HGF system for a range of conditions, including Alzheimer’s, Parkinson’s, Dementia with Lewy bodies, and amyotrophic lateral sclerosis.