Athira Pharma to Present Fosgonimeton Phase 2/3 LIFT-AD Trial Results at CTAD 2024

Athira Pharma, Inc., based in Bothell, Washington, has announced that findings from its Phase 2/3 LIFT-AD clinical trial concerning fosgonimeton for Alzheimer’s disease (AD) will be showcased at the 17th Annual Clinical Trials on Alzheimer’s Disease (CTAD) from October 29 to November 1, 2024, in Madrid, Spain. The presentation, titled "Fosgonimeton for the Treatment of Alzheimer’s Disease: Efficacy and Safety Results from the LIFT-AD Trial," is scheduled for October 29 at 5:10 p.m. CET and will be led by Dr. Anton P. Porsteinsson, Director of the University of Rochester Alzheimer’s Disease Care, Research, and Education Program, who is also an investigator in the LIFT-AD trial.

The top-line results from the LIFT-AD trial revealed that fosgonimeton did not meet the primary endpoint of the Global Statistical Test (GST) nor the key secondary endpoints when compared to a placebo over a 26-week period. Despite not achieving statistical significance, the treatment with fosgonimeton showed a directional preference in both cognition (measured by ADAS-Cog11) and function (measured by ADCS-ADL23). Notably, in pre-specified subgroups characterized by rapid disease progression, such as those with moderate AD and APOE4 carriers, there were improvements or stabilization in cognition and function in patients treated with fosgonimeton.

Moreover, the trial's data indicated favorable changes in biomarkers associated with protein pathology (Aβ42/40, p-Tau181, and p-Tau217), inflammation (GFAP), and neurodegeneration (NfL), aligning with the neuroprotective mechanism of hepatocyte growth factor (HGF) modulation. Dr. Javier San Martin, Chief Medical Officer of Athira, highlighted the potential of HGF modulation in treating neurodegenerative diseases based on the overall data from the study.

Athira Pharma is also progressing with the development of ATH-1105, an innovative, oral, next-generation small molecule that positively modulates the neurotrophic HGF system. This compound is being considered for treating neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and Alzheimer’s disease. Currently, Athira is conducting a first-in-human Phase 1 trial (NCT 06432647), which is a double-blind, placebo-controlled study involving up to 80 healthy volunteers. This study aims to assess the safety and tolerability of ATH-1105 and includes evaluations of pharmacokinetic outcomes. The initial cohort of this study was completed in June 2024, and the full study is expected to conclude by the end of 2024, with the aim to begin dosing ALS patients in 2025.

Athira Pharma, Inc. is a clinical-stage biopharmaceutical company dedicated to developing small molecules to enhance neuronal health and mitigate neurodegeneration. The company is headquartered near Seattle, Washington, and is working towards altering the progression of neurological diseases through its pipeline of drug candidates that modulate the neurotrophic HGF system.