Athira Pharma Announces Completion of Enrollment in Phase 2 ACT-AD Trial Evaluating ATH-1017 for Mild-To-Moderate Alzheimer?S Disease
October 22, 2021 at 08:22 am EDT
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Athira Pharma, Inc. announced that it has completed enrollment in ACT-AD, a Phase 2 randomized, placebo-controlled study of ATH-1017 in patients with mild-to-moderate Alzheimer?s disease. ATH-1017 is a small molecule designed to enhance the activity of Hepatocyte Growth Factor (HGF) at its receptor, MET, which are expressed in the central nervous system to promote brain health and function. Athira expects to report topline results from the trial in the first half of 2022. The ACT-AD study (www.act-adtrial.com, NCT04491006) is a randomized, double-blind, placebo-controlled, 26-week Phase 2 clinical trial. Participants were randomized across two dose groups and one placebo group on a 1:1:1 basis to receive a daily subcutaneous injection of ATH-1017 or placebo over a treatment course of 26 weeks. The study has enrolled 77 patients with mild-to-moderate Alzheimer?s disease across 14 sites in the United States and Australia. Patients will be evaluated for improvement in cognition, global, and functional assessments comparing treatment arms to placebo. ACT-AD will also use electroencephalogram (EEG), to measure quantitative electroencephalogram (qEEG), and Event-Related-Potential (ERP P300), a functional measure of working memory processing speed. Following completion of the 26-week treatment period during the LIFT-AD or ACT-AD trials, patients may elect to continue on the open label extension and receive treatment with ATH-1017 at the high dose (70 mg/day) for up to an additional 26 weeks.
Athira Pharma, Inc. is a late clinical-stage biopharmaceutical company. It focuses on developing small molecules engineered to restore neuronal health and slow neurodegeneration. Its pipeline consists of both blood brain barrier permeable and peripherally restricted drug candidates for the central nervous system (CNS), peripheral nervous system, and other indications. Its lead candidate, fosgonimeton (ATH-1017), is a subcutaneously administered, small molecule positive modulator of the hepatocyte growth factor/mesenchymal-epithelial transition factor (HGF/MET) system for CNS disorders. It is also evaluating other drug candidates for the potential treatment of neuropathic pain, amyotrophic lateral sclerosis, Parkinson's disease, and other neurodegenerative diseases. Its ATH-1020 has completed a Phase I single ascending dose evaluation in healthy volunteers. Its ATH-1105 is a small molecule compound designed to be an orally available, once-daily treatment to enhance the HGF/MET system.