P300, a test that measures the neural electrical activity to assess how quickly the brain processes information from external stimuli.
The number 300 refers to 300 milliseconds—the average response time for a healthy individual, Litton says. Those who have dementia or other neurodegenerative diseases register a higher number, reflecting the longer amount of time it takes for their brains to process information. At 450 milliseconds, the delay is considered severe. The average of the Alzheimer’s patients entering the Athira study was 400 milliseconds.
The Phase 1 results showed that after eight days of treatment with the Athira drug, Alzheimer’s patients showed an average improvement of 73 milliseconds—enough to be statistically significant. It’s a small sample, but Litton says it’s a promising start. The next step is to show in a larger clinical trial that the gain observed in the P300 test translates to cognitive improvement.
Earlier this month, Athira began a Phase 2/3 clinical trial testing two doses of ATH-1017. The study is expected to enroll up to 300 patients. In addition to further evaluating the drug’s safety, the 26-week study will also gauge efficacy measured by tests commonly used to assess Alzheimer’s patients. Preliminary data are expected by the end of 2022, according to the IPO filing.
A second Phase 2 study will test the same doses in up to 75 patients. This study, also 26 weeks, will evaluate memory processing speed and cognition, using standard measures for assessing Alzheimer’s patients. Preliminary results are expected early 2022.
P300 won’t be used as a clinical trial endpoint in the clinical studies, as it’s not regarded as a standard measure for Alzheimer’s, Kawas says. But she adds that it’s a validated measure of cognitive processing and there are FDA approved drugs that have shown a correlation between a patient’s P300 score and brain improvement.
Athira sold 12 million shares in its IPO, which was priced at $17 per share, the high end of its projected price range. The company initially planned to sell 10 million shares in the range of $15 and $17 each. According to Athira’s prospectus, $75 million of the IPO proceeds are set aside for the two Phase 2 tests of ATH-1017 in Alzheimer’s. Another $20 million is earmarked for a Phase 2 study testing that drug in Parkinson’s disease dementia. The Athira pipeline has two other compounds in the pipeline, one for neuropsychiatric disorders and the other for neuropathy. The company plans to spend $30 million on preclinical research to advance both to human testing.
Image: iStock/AlexLMX
 |
Want more Xconomy content? Subscribe today for free newsletters, event and webinar alerts, whitepapers, podcasts, and more. |
