The clinical-stage biopharma Athira Pharma (Nasdaq:ATHA) has published a review paper stressing the need for new treatments for Alzheimer’s disease.
The paper also states that one of its small molecule drugs, fosgonimeton, holds potential for treating Alzheimer’s.
The Journal of Alzheimer’s Disease published the paper titled “The Case for a Novel Therapeutic Approach to Dementia: Small Molecule Hepatocyte Growth Factor (HGF/MET) Positive Modulators.”
ATHA shares were down 1.24% to $3.99 in pre-market trading.
Moving beyond ACT-AD
In June 2022, Athira Pharma revealed disappointing results from the Phase 2 ACT-AD trial focused on Alzheimer’s disease. The study did not show a statistically significant change in ERP P300 latency (a measure of cognitive function) for the modified intent-to-treat population. Fosgonimeton recipients were divided into 40 mg and 70 mg dose groups. Investigators performed a pooled analysis after 26 weeks.
The company expects topline data from its Phase 2/3 LIFT-AD study in mild-to-moderate Alzheimer’s disease in early 2024.
An independent data monitoring committee recommended continuing the study in patients with mild-to-moderate Alzheimer’s in October after an unblinded interim efficacy and futility analysis.
Athira’s lead drug candidate is fosgonimeton, which is in a Phase 2/3 study for mild-to-moderate Alzheimer’s disease. The neurodegeneration-focused company aims to offer innovative therapeutics for Alzheimer’s disease and other neurodegenerative conditions through the modulation of the HGF/MET system.
Other matters
In 2021, Athira Pharma said its former CEO, Lee Kawas, and cofounder would step down following research misconduct allegations. She has gone on to found an investment firm known as Propel Bio Partners.
Mark Litton is the company’s current CEO.
In early 2023, FDA granted accelerated approval to Leqembi (lecanemab) from Eisai (OTCMKTS:ESALY) and Biogen (Nasdaq:BIIB). Eisai set an annual launch price of $26,500 for the amyloid beta-protein inhibitor.
Athira is focused on developing novel small molecule positive modulators targeting the hepatocyte growth factor (HGF) and mesenchymal-epithelial transition factor (MET) system.