Athira Pharma to present results from Phase 2/3 LIFT-AD trial

Athira Pharma (ATHA) announced that results from the Phase 2/3 LIFT-AD clinical trial of fosgonimeton to treat Alzheimer’s disease will be presented at the 17th Annual Clinical Trials on Alzheimer’s Disease taking place October 29 – November 1, 2024, in Madrid, Spain. Presentation Details: Title: Fosgonimeton for the Treatment of Alzheimer’s Disease; Efficacy and Safety Results from the LIFT-AD Trial Session: Oral Communications: OC2 Date/Time: Tuesday, October 29 at 5:10 p.m., CET Presenter: Anton P. Porsteinsson, M.D., Director of the University of Rochester Alzheimer’s Disease Care, Research, and Education Program and a LIFT-AD investigator As previously reported, topline results from the LIFT-AD trial did not achieve statistical significance for the primary endpoint of the Global Statistical Test nor its key secondary endpoints compared with placebo at 26 weeks. However, both components of GST, cognition and function, directionally favored fosgonimeton treatment, and in pre-specified subgroups characterized by more rapid disease progression, cognition and function improved or stabilized in the fosgonimeton treated group. In addition, data across biomarkers of protein pathology, inflammation and neurodegeneration showed directional changes in favor of fosgonimeton treatment that are consistent with the broad neuroprotective mechanism of HGF modulation. “We believe the totality of the data supports the potential of HGF modulation for the treatment of neurodegenerative diseases,” said Javier San Martin, CMO. Athira is focused on advancing the clinical development program for ATH-1105, a novel, oral, next-generation small molecule positive modulator of the neurotrophic hepatocyte growth factor system, as a potential treatment for neurodegenerative diseases, including amyotrophic lateral sclerosis and Alzheimer’s disease. Athira is conducting a first-in-human Phase 1 double-blind, placebo-controlled trial that is enrolling up to 80 healthy volunteers. The study is evaluating the safety and tolerability of ATH-1105 and includes measurements of pharmacokinetic outcomes. Athira completed the first cohort of healthy volunteers in June 2024 and expects to complete the full study by year-end 2024, with a goal to begin dosing ALS patients in 2025.