Athira Pharma announces results from ACT-AD Phase 2 study of fosgonimeton

Athira Pharma announced topline results from its exploratory ACT-AD Phase 2 study of fosgonimeton, ATH-1017, in patients with mild-to-moderate Alzheimer's disease. Fosgonimeton is a small molecule designed to enhance the activity of Hepatocyte Growth Factor and its receptor, MET, which are expressed in the central nervous system to promote brain health and function. "Following compelling ERP P300 latency biomarker data from a small Phase 1b trial over eight days in Alzheimer's patients on fosgonimeton monotherapy, this Phase 2 trial provides valuable insights into the nature of this novel intervention over 26 weeks. ACT-AD was designed as a learning study to further investigate the ERP P300 biomarker signal over 6 months, assess safety in a patient population more representative of the real world, by allowing the use of add-on standard-of-care acetylcholinesterase inhibitors, and explore fosgonimeton's effect on psychometric outcomes, including ADAS-Cog11, to inform the ongoing Phase 3 LIFT-AD study. To that end, this study achieved its goal," said Hans Moebius, M.D., Ph.D., Chief Medical Officer of Athira. "These data points are very encouraging as they indicate the expected pharmacological activity of fosgonimeton by parallel improvement on ERP P300 latency and ADAS-Cog11 and show a favorable safety profile over six months. This is the first time monotherapy fosgonimeton has shown an effect on ADAS-Cog11, suggesting a potential cognitive benefit. We will use these insights for a rational optimization of the ongoing LIFT-AD trial. We plan to seek advice from our scientific advisors, investigators, and ultimately regulators on how to expeditiously analyze and potentially adapt the LIFT-AD study," added Dr. Moebius