Athira Pharma Announces Initiation of Patient Dosing in SHAPE, a Phase 2 Clinical Trial of ATH-1017 for the Treatment of Parkinson's Disease Dementia & Dementia with Lewy Bodies

Athira Pharma, Inc. recently announced patient dosing has begun in SHAPE, a Phase 2 clinical trial of ATH-1017 for the treatment of Parkinson’s disease dementia and Dementia with Lewy bodies. ATH-1017 is a small molecule designed to enhance the activity of Hepatocyte Growth Factor (HGF) and its receptor, MET, to impact neurodegeneration and regenerate brain tissue.

“The initiation of SHAPE is an important milestone in the advancement of our clinical development of ATH-1017. This small molecule is designed to impact neurodegeneration by focusing on network recovery and information transmission in the brain,” said Hans Moebius, MD, PhD, Chief Medical Officer at Athira. “SHAPE incorporates key endpoints to measure cognition, function and behavior, as well as including exploratory endpoints for motor function. We are excited to expand our clinical development of ATH-1017 with the SHAPE trial in other dementia indications that affect so many around the world, beyond Alzheimer’s disease.”

“There is a critical need for new therapeutic approaches that address the neurodegenerative effects experienced by patients with Parkinson’s disease dementia and Dementia with Lewy bodies,” said Daniel Burdick, MD, SHAPE Principal Investigator and Medical Director at EvergreenHealth. “SHAPE is an important step to advance a novel investigational approach that could potentially restore brain function to patients living with these progressive neurological diseases.”

SHAPE is a randomized, double-blind, placebo-controlled, parallel-group Phase 2 trial for ATH-1017 in subjects with Parkinson’s disease dementia or Dementia with Lewy bodies. The study will enroll approximately 75 individuals in the United States. Study participants are randomized across two dose groups and one placebo group on a 1:1:1 basis to receive a subcutaneous injection of ATH-1017 or placebo once daily over a treatment course of 26 weeks. The primary endpoint for SHAPE is the composite Global Statistical Test, which is an unbiased mathematical algorithm that combines the scores from the cognitive assessment and change in Event-Related-Potential (ERP) P300 latency, a functional measure of working memory processing speed. Additional information on the study can be found at: https://clinicaltrials.gov/ct2/show/NCT04831281.

ATH-1017 is a small molecule, specifically designed to enhance the activity of Hepatocyte Growth Factor (HGF) and its receptor, MET. The function of this neuroreceptor system may be impaired under conditions of neurodegeneration. In addition to Alzheimer’s disease, ATH-1017 is designed to address the broader dementia population, including Parkinson’s disease dementia and Dementia with Lewy bodies, as the mechanism of action focuses on network recovery and synaptic signal transmission in the brain, which has the potential to improve clinical outcomes for patients suffering from diverse neurodegenerative conditions.

Nearly 1 million people in the US and more than 10 million people globally are living with Parkinson’s disease (PD). While those with PD commonly experience deficits in motor symptoms, around 50% suffer from Parkinson’s disease dementia (PDD), a progressive neurodegenerative disorder, defined by changes in thinking, memory, and behavior. Only a single therapy is currently approved for PDD, and more specific and novel approaches addressing this disease are needed.

Dementia with Lewy bodies (DLB) is the third most common cause of dementia accounting for 5-15% of all dementia cases globally. In general, DLB and PDD are clinically distinguished by the initial sequence of dementia symptoms.

Both PDD and DLB account for an underserved dementia population. With a lack of specific therapies today for either PDD or DLB, there is a substantial need for a therapy with the potential to slow or stop synaptic loss and neurodegeneration, the main underlying condition contributing to progressive deterioration in dementia symptoms.

Athira, headquartered in the Seattle area, is a late clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and stop neurodegeneration. Athira aims to provide rapid cognitive improvement and alter the course of neurological diseases with our novel mechanism of action. Athira is currently advancing its lead therapeutic candidate, ATH-1017, a novel small molecule for Alzheimer’s and Parkinson’s disease dementia and Dementia with Lewy bodies. For more information, visit www.athira.com.