Athira Pharma (NASDAQ:ATHA) dropped ~67% in the pre-market Wednesday after the clinical-stage biotech announced that its lead product candidate, fosgonimeton (ATH-1017), did not meet key goals in a mid-stage trial involving patients with mild-to-moderate Alzheimer’s disease (AD).
The primary endpoint of the ACT-AD Phase 2 study was Event-Related-Potential (ERP) P300 Latency, a functional measure of working memory processing speed.
The trial conducted in the U.S. and Australia involving 77 patients was designed to assess 40 mg/d or 70 mg/d of fosgonimeton.
The topline data indicated that the study did not meet the primary endpoint with a statistically significant change in ERP P300 Latency for the full study population compared with placebo at 26 weeks.
Even secondary endpoints of the trial, including AD clinical measures such as ADAS-Cog11, ADCS-CGIC, and ADCS-ADL23, were not significant compared to placebo at 26 weeks.
Fosgonimeton is designed to augment the activity of Hepatocyte Growth Factor (HGF) and its receptor, MET that are expressed in the central nervous system and believed to promote brain health and function.
Wall Street has remained bullish on Athira (ATHA) stock, with an average rating of Strong Buy from analysts. However, Seeking Alpha's quant system, which consistently beats the market, rated ATHA as a Hold.