First Patient Dosed in Phase 2 Trial of MET Receptor Inhibitor for Potential Dementia Treatment
The first individual has been given a dose in the phase 2 randomized placebo-controlled study (NCT04491006) of a MET tyrosine kinase receptor activator (ATH-1017; Athira Pharmaceuticals, Seattle, CA) for potential treatment of Alzheimer disease (AD). The MET receptor is the receptor for hepatocyte growth factor (HGF). The MET receptor activator is thought to promote neuronal survival and plasticity (synaptogenesis).
“This Alzheimer treatment approach is innovative and novel. As part of the study design, the use of qEEG and ERP 300 as physiologic outcome measures and indicators of improved function in brain networks could be highly valuable to the field as a whole, ” said Charles Bernick, MD, MPH, clinical professor, University of Washington School of Medicine, Department of Neurology, coinvestigator, University of Washington AD Research Center and director of Clinical trials, UW Medicine Memory & Brain Wellness Center.
"The initiation of our second late-stage study for ATH-1017 represents a significant milestone for Athira as we advance our clinical program to treat this area of immense medical need," said Hans Moebius, MD, PhD, chief medical officer at Athira. "Athira’s novel treatment approach is agnostic to the underlying disease pathology of AD and other dementias. 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."
The phase 2 ACT-AD clinical trial will enroll an estimate of 75 individuals with mild-to-moderate AD. Participants will be randomly assigned 1:1 to receive a daily subcutaneous injection of the MET receptor activator or placebo for 26 weeks. Changes in cognition, global, and functional assessments will be evaluated and quantitative electroencephalogram (qEEG) as a functional measure of the working memory processing speed will also be done. Results from the ACT-AD trial may provide supportive information that can help improve the LIFT-AD study (NCT04488419) as a potentially pivotal trial.
The therapeutic is designed to address the broader dementia population, including AD and Parkinson disease dementia.