Both ongoing ACT-AD and LIFT-AD studies are assessing Athira’s investigational therapy ATH-1017.
Athira Pharma has been awarded a $15 million grant from the National Institute on Aging to support its phase 2 randomized, placebo-controlled ACT-AD trial (NCT04491006) investigating ATH-1017 for mild-to-moderate Alzheimer disease (AD).1
ATH-1017, a small-molecule therapeutic, promotes the activity of Hepatocyte Growth Factor (HGF) and its receptor, MET, which are expressed in the central nervous system, in order to enhance brain health and function.2
Co-investigator Charles Bernick, MD, MPH, Clinical Professor, Department of Neurology, University of Washington School of Medicine, University of Washington Alzheimer’s Disease Research Center and Director of Clinical trials, UW Medicine Memory & Brain Wellness Center, said in a statement that “this AD treatment approach is innovative and novel. As part of the study design, the use of quantitative electroencephalogram (qEEG) and Event-Related-Potential (ERP 300) as physiological outcome measures and indicators of improved function in brain networks could be highly valuable to the field as a whole."
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The trial plans to enroll around 75 patients with mild-to-moderate AD from the US and Australia. These patients will be randomized to either placebo or 1 of 2 dose groups of ATH-1017. Patients will receive a daily subcutaneous injection of either ATH-1017 or placebo over 26 weeks. ERP 300, a functional measure of working memory processing speed and executive function, and qEEG will be used to evaluate improvement in cognition, global, and functional assessments in treatment and placebo groups.
Hans Moebius, MD, PhD, Chief Medical Officer, Athira Pharma, said in a statement that "Athira’s novel treatment approach is agnostic to the underlying disease pathology of Alzheimer’s 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 Alzheimer’s disease and preserve cognitive health."
This announcement follows a few weeks after Athira Pharma announced that the ACT-AD trial had initiated dosing. The company’s LIFT-AD phase 2/3 clinical trial (NCT04488419), also investigating ATH-1017, initiated dosing in October 2020. It will enroll up to 300 patients with mild-to-moderate AD and will investigate ATH-1017's efficacy in terms of cognitive improvements and performance on global/functional assessments between placebo and treatment groups.3 Findings in ACT-AD, such as appropriate dosage, may influence trial methods and outcome measures of LIFT-AD.
“Data from our previous study show functional biomarker effects indicating potentially positive effects of ATH-1017 on brain function in Alzheimer’s patients,” Moebius said in a statement. “Our goal is to confirm these compelling effects in a larger ATH-1017 study as there is a significant unmet need for new Alzheimer’s treatments.”