Athira announces clinical trials for Alzheimer’s, Parkinson’s, ALS treatments in 2023
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Athira Pharma Inc. revealed its list of planned clinical trials for 2023, which include development of therapeutics for Alzheimer’s disease, Parkinson’s disease and ALS.
According to a company release, four studies are in the works along with continued investigation of fosgonimeton, a small molecule designed to boost hepatocyte growth factor (HGF) and its receptor, MET, which may offer protection and repair of neural networks and slow neurodegeneration.
“Our dedication to advancing new therapeutics to impact neurodegenerative diseases remains steadfast,” Mark Litton, PhD, president and CEO at Athira, stated in the release. “The totality of our data shared in 2022 strengthens our confidence in and supports the potential of our small molecule approach targeting the HGF/MET system for diseases including Alzheimer’s, Parkinson’s and ALS.”
With results in from the exploratory phase 2 ACT-AD trial, Athira launched the phase 2/3 LIFT-AD trial to examine fosgonimeton’s effectiveness compared with placebo in patients with mild-to-moderate AD, with enrollment expected to be complete in mid-2023 and topline data anticipated in early 2024. Concurrently, an open-label extension study including more than 200 individuals who have completed either ACT-AD or LIFT-AD is ongoing.
The company has also enrolled 28 individuals in the exploratory phase 2 SHAPE study, which aims to assess fosgonimeton in individuals with dementia related to Parkinson’s disease or Lewy body dementia. Per the release, once treatment is concluded, Athira will assess data and determine future endeavors.
Athira also announced completion of a phase 1, single-ascending, dose escalation study of ATH-1020, an orally administered small molecule created to enhance the HGF/MET system as a potential treatment for neuropathic pain. The novel therapeutic demonstrated a favorable safety profile and was well-tolerated among healthy participants, the company stated in the release.
Plans to file an investigative new drug application for ATH-1105 as a potential treatment for ALS, with the goal of commencing first-in-human studies, are also underway.
“The consistency of data from preclinical models across various neurodegenerative diseases and in Alzheimer’s patients suggest that our small molecule product candidates may be neuroprotective, neurotrophic, procognitive and potentially disease-modifying,” Litton said. “Athira has an exciting year ahead.”