First Dose of Potential Neuroprotective Agent Administered in Phase 2/3 Trial for Mild-to-Moderate AD
Treatment administration has begun in a phase 2/3 clinical trial evaluating a once-daily , MET receptor tyrosine kinase (METR) activator (ATH-1017; Athira Pharma Inc., Seattle, CA for potential treatment of mild-to-moderate Alzheimer disease (AD)). The METR activator is thought to have neuroprotective effects.
"Data from our previous study show functional biomarker effects indicating potentially positive effects of ATH-1017 on brain function in AD patients,” said Hans Moebius, MD, PhD, chief medical officer at Athira. “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.”
The phase 2/3 clinical trial (NCT04488419), is a randomized double-blind placebo-controlled trial evaluating the safety and efficacy of a METR activator. Clinical efficacy will be measured by improvement in cognition and functional assessments. Approximately 300 participants will be randomly assigned across 2 dose groups and 1 placebo group on a 1:1:1 basis to receive a daily subcutaneous injection of a METR activator or placebo over a course of 26 weeks.
"Embarking on this trial to evaluate our new approach to treating Alzheimer is the start of a collective experience that will involve not only individuals with Alzheimer but their caregivers and family members,” said Leen Kawas, PhD, president and chief executive officer at Athira. “We appreciate the collaborative efforts that are underway to evaluate the potential of ATH-1017 to improve mild-to-moderate AD.”
The completed phase 1a/b clinical trials of a METR activator for the treatment of AD established that the treatment was generally well tolerated. Measures evaluating brain function with electroencephalogram (qEEG) also produced a collection of translational data. A significant improvement in Event-Related Potential (ERP) P300 latency was noted in individuals with AD following multiple dose treatment with a METR activator compared with those receiving placebo. Through the LIFT-AD clinical trial and other anticipated clinical trials, a connection between these P300 latency results and improved cognition is sought to be established.