Athira Pharma provides 2023 outlook for Alzheimer's, Parkinson’s, ALS trials
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Athira Pharma Inc. will proceed in 2023 with several clinical trials for treatments for Alzheimer’s disease, Parkinson’s disease and ALS, the biopharmaceutical company announced in a press release.
“Our dedication to advancing new therapeutics to impact neurodegenerative diseases remains steadfast,” Athira President and CEO Mark Litton, PhD, said in the release.
Athira is currently testing candidate ATH-1017, or fosgonimeton, a small molecule designed to enhance the activity of hepatocyte growth factor (HGF) and its receptor, MET, which has the potential to protect and repair neural networks, the release stated.
The company plans to complete enrollment in mid-2023 for a phase 2/3 study of patients with mild to moderate AD to compare the effects of fosgonimeton with placebo. Topline data is expected in early 2024.
“We believe the independent, unblinded interim efficacy and futility analysis of the phase 2/3 study mitigates fosgonimeton program risk, supports the potential clinical benefits of fosgonimeton treatment and underscores the rationale for continued development of this promising potential new therapy,” Litton said in the release.
In addition, Athira has enrolled 28 patients with PD dementia or dementia with Lewy bodies to participate in a phase 2 trial for fosgonimeton.
“With the compelling preclinical data recently presented on the broader potential of fosgonimeton to improve motor function in Parkinson’s disease, [Athira] will seek to evaluate study designs that will further explore its potential in this complex disease,” the release stated.
Athira also will assess candidate ATH-1020, an orally available treatment designed to enhance the HGF/MET system and a potential treatment candidate for neuropathic pain and neurodegenerative disease. In a phase 1 trial for ATH-1020, the candidate demonstrated a favorable safety profile and was well-tolerated in healthy volunteers.
Athira’s final candidate, ATH-1105, is a small molecule positive modulator of the HGF/MET system and a potential candidate for ALS. Preclinical data was presented in December 2022. The company plans to submit an investigational new drug application to the FDA in 2023 to initiate human trials.
“Importantly, we have a strong balance sheet that enables us to continue to explore the potential of fosgonimeton in Alzheimer’s and Parkinson’s disease dementia and dementia with Lewy body and to advance other programs, such as ATH-1105 in ALS, through to key inflection points,” Litton said.