Athira initiates dosing in Phase 2 Alzheimer’s disease study

Athira Pharma (NASDAQ:ATHA) initiated patient dosing in its ACT-AD Phase 2 trial evaluating ATH-1017 in patients with mild-to-moderate Alzheimer’s disease (AD).

ATH-1017 is a small molecule designed to regenerate brain tissue by enhancing the activity of hepatocyte growth factor and its receptor, MET.

The trial will enroll some 75 AD patients who will receive a daily subcutaneous injection of one-of-two doses of ATH-1017, or placebo, for a treatment course of 26 weeks. Patients will be evaluated for improvement in cognition, global, and functional assessments, comparing treatment arms with placebo. 

The trial also will use quantitative electroencephalogram and event-related-potential, a functional measure of working memory processing speed and executive function.

The company said the ACT-AD trial may provide supportive information that can help optimize LIFT-AD – a 300-patient Phase 2/3 AD trial launched in October 2020 – as a potentially pivotal trial. 

“Athira’s novel treatment approach is agnostic to the underlying disease pathology of AD and other dementias,” Dr. Hans Moebius, Athira’s CMO, said in a statement.

“It focuses on network recovery and information transmission in the brain, which has the potential to improve clinical outcomes for patients. Our goal, with both this ACT-AD study and the LIFT-AD study, is to demonstrate the clinical utility of this promising agent to treat AD and preserve cognitive health,” he added.