Athira Pharma, Inc. (ATHA) stock prices were down by a marginal 1.67% as of the market closing on June 17th, 2021, bringing the price per share down to USD$18.24 at the end of the trading day. After-hours trading saw the company’s stock plummet by a massive 34.21%, bringing it down to USD12.00.
The company has been actively recruiting subjects for its LIFT-AD trial, with top-ling data anticipated for the end of 2022. The Phase 2/3 clinical trial is randomized, double-blind, and placebo-controlled, and is designed to evaluate the safety, efficacy, and tolerability of ATH-1017 in patients with mild to moderate Alzehimers disease. With plans to enroll almost 300 patients, the treatment course will span a period of 26 weeks, with participants being randomized across two dose groups and one placebo group. The treatment’s clinical efficacy will be determined by improvements in cognition and global/functional assessments as compared to the results from the placebo group.
ATH-1019/1020 are innovative, small molecule compounds that are designed to be administered as an oral, once-daily treatment. The treatments also activate HGF/MET systems, as well as the distribution to the central nervous system as potential candidates for depression, anxiety, and other neuropsychiatric indications.
IND Filing of ATH-1019/1020
IND filing for ATH-1019 and ATH-1020 is expected for the end of 2021, with IND-enabling studies currently being carried out. Decisions on the selection of the lead product candidate will be informed by late-stage clinical development work and potentially early clinical studies.
The company is also actively recruiting for its ACT-AD trial, with reports of top-line data by early 2022. The Phase 2 clinical trial is randomized and placebo-controlled and is designed to evaluate ATH-1017. ATH-1017 is a once-daily investigational drug for the treatment of mild-to-moderate Alzheimer’s disease. Roughly 75 patients are expected to be enrolled in the U.S. and Australia.
Details of the Trial
The treatment course will span 26 weeks, with participants being evaluated for improvements in cognition, global and functional assessments as compared to treatment arms that received the placebo. The treatment will also use EEGs to measure qEEG and ERP P300, which is a functional measure of working memory processing speed and executive function. The clinical development strategy for any additional trials of ATH-1017 will be informed by results from the ACT-AD trial.
Future Outlook for ATHA
Armed with recent developments in their pipeline of products, ATHA is poised to continue its trajectory of success. The company is keen to push for the commercialization and proliferation of its treatments in development at the moment. Current and potential investors are hopeful that management will continue to leverage the resources at their disposal to facilitate significant and sustained increases in shareholder value.