1st Patient Treated in SHAPE Trial of ATH-1017 for Parkinson’s Dementia
Athira Pharma has dosed the first patient in its Phase 2 clinical trial evaluating ATH-1017 as a treatment for Parkinson’s disease dementia (PDD) and dementia with Lewy bodies (DLB) — forms of more severe cognitive impairment in Parkinson’s disease.
The trial (NCT04831281), known as SHAPE, is still recruiting patients, ages 40-85, at five different locations across the United States. More information can be found here.
“The initiation of SHAPE is an important milestone in the advancement of our clinical development of ATH-1017,” Hans Moebius, MD, PhD, chief medical officer at Athira, said in a press release.
ATH-1017 — given as an under-the-skin (subcutaneous) injection — is a small molecule intended to enhance the activity of hepatocyte growth factor (HGF) and its receptor, MET. Both HGF and MET are found within the central nervous system, which comprises the brain and spinal cord.
When HGF is bound to its receptor, it promotes cell growth, migration, and new blood vessel formation. By enhancing the activity of this signaling pathway, ATH-1017 is expected to improve brain health and function.
“This small molecule is designed to impact neurodegeneration by focusing on network recovery and information transmission in the brain,” Moebius said.
The therapy’s focus is on the recovery of neuronal connections and messaging within the brain. It has the potential to improve clinical outcomes for patients with a variety of neurodegenerative conditions. ATH-1017 is currently in clinical trials for the treatment of mild Alzheimer’s disease.
Both PDD and dementia with Lewy bodies have been shown to share some common genes, and account for an underserved dementia population, according to Athira.
“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, a SHAPE principal investigator and medical director at EvergreenHealth, in Washington.
SHAPE is a placebo-controlled Phase 2 trial for people with a confirmed diagnosis of PDD or dementia with Lewy bodies. The trial intends to enroll 75 patients who will be randomly selected to receive either a high or low dose of ATH-1017 — given as a daily under-the-skin injection — or a placebo over the course of 26 weeks, or six months.
The primary goal is to assess the overall treatment effect of ATH-1017 as evaluated by changes in the Global Statistical Test, a formula that combines a cognitive assessment with a test for functional working memory processing speed. Additionally, changes in activities of daily living and motor function will be evaluated.
“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,” Moebius said.
Added Burdick, “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.”
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