The neurodegeneration-focused biopharma Athira Pharma (Nasdaq:ATHA) has seen its stock drop more than 90% since December 31, 2020. Today alone, the company’s share price was down 66.73%, falling to $2.81, in mid-day trading after the company announced disappointing results from the Phase 2 ACT-AD study focused on fosgonimeton in Alzheimer’s disease.
The company announced that the study failed to meet its primary endpoint, which involved a statistically significant change in event-related potential (ERP) P300 latency.
P300 is a measure of decision-making detected using electroencephalography (EEG).
Athira did note the suggestion of a positive effect in a pre-specified subgroup analysis in ERP P300 latency and Alzheimer’s Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) at week 26 relative to placebo.
“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,” said Dr. Hans Moebius, chief medical officer of Athira, in a news release.
“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 (AChEIs, e.g., donepezil), 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.”
Moebius noted that a post hoc analysis related to the study showed a “meaningful improvement” in ERP P300 latency (-28 milliseconds) and cognitive performance (ADAS-Cog11: -3.3 points) relative to placebo.
The drug candidate was generally well tolerated in the study.
Post hoc analyses played a role in convincing Biogen (Nasdaq:BIIB) to pursue market authorization for Aduhelm (aducanumab), a controversial drug that has faced a series of setbacks over the past year.
Filed Under: Neurological Disease