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Athira Pharma Inc (NASDAQ: ATHA) shares are falling to 52-week lows after announcing disappointing topline results from its exploratory ACT-AD Phase 2 study of fosgonimeton (ATH-1017) in mild-to-moderate Alzheimer's disease (AD).
The study did not meet the primary endpoint of a statistically significant change in ERP P300 Latency for the modified intent to treat (mITT) population when compared with placebo at 26 weeks in a pooled analysis of the 40 mg and 70 mg dose groups.
Secondary endpoints, including ADAS-Cog11, ADCS-CGIC, and ADCS-ADL23, were not significant in treated subjects compared with placebo at 26 weeks. Pre-specified subgroup analysis identified a potential diminished effect of the combination of standard-of-care (AChEIs) and fosgonimeton. Other subgroup analyses did not show differences between groups, including dose, disease severity, and APOE genotype.
A post hoc analysis showed a potentially beneficial change in ERP P300 compared to placebo at 26 weeks and cognitive improvement as measured by ADAS-Cog11 (-3.3 points) compared with placebo at 26 weeks.
Fosgonimeton was generally well tolerated, with a favorable safety profile. No treatment-related Serious Adverse Events or deaths were observed in the study.
Price Action: ATHA shares are down 65.1% at $2.95 during the premarket session on the last check Wednesday.
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