Athira Pharma, Inc. (ATHA) experienced a significant decline in its stock price on Wednesday following the release of topline results from its Phase 2/3 LIFT-AD clinical trial for fosgonimeton, a drug targeting mild-to-moderate Alzheimer’s disease (AD). The trial’s primary endpoint, a combination of cognitive and functional measures, did not achieve statistical significance, leading to disappointment among investors.
The trial’s results showed a small improvement in cognition for the fosgonimeton-treated group compared to placebo, but this difference did not reach statistical significance. Additionally, while the drug demonstrated a positive impact on function, this improvement also fell short of statistical significance.
Despite the overall lack of statistical significance, the company highlighted some encouraging trends. Notably, a subgroup of patients with more advanced Alzheimer’s disease showed a larger numerical improvement in clinical outcomes with fosgonimeton treatment. Similarly, patients carrying the APOE4 gene, a genetic risk factor for Alzheimer’s, exhibited stable cognition while the placebo group showed a decline.
Further analysis by disease severity revealed a larger effect size for fosgonimeton, particularly in patients with the highest baseline cognitive impairment. These patients demonstrated a significant improvement in cognition after treatment with fosgonimeton.
Despite these positive trends in subgroups, the overall results of the trial were deemed insufficient to support the efficacy of fosgonimeton for mild-to-moderate Alzheimer’s disease. Athira Pharma’s Chief Medical Officer, Javier San Martin, acknowledged that the trial’s short duration and the lack of clinical decline in the placebo group might have contributed to the inability to demonstrate a clear benefit from fosgonimeton treatment.
Following the release of these disappointing results, ATHA stock plunged by 72.8% during premarket trading, reflecting the market’s negative reaction to the failed trial. This event underscores the ongoing challenges in developing effective treatments for Alzheimer’s disease, a complex and debilitating neurodegenerative disorder.
