Athira Pharma Completes First Phase 1 Cohort for ALS Drug ATH-1105

Athira Pharma, Inc., a biopharmaceutical company based in Bothell, Washington, is focusing on developing therapies to restore neuronal health and slow neurodegeneration. The company recently announced the completion of the first cohort of healthy volunteers in its Phase 1 clinical trial for ATH-1105, marking a significant milestone in its development. This trial aims to evaluate the safety, tolerability, and pharmacokinetics of ATH-1105, an oral small molecule designed to modulate the neurotrophic hepatocyte growth factor (HGF) system, which is being developed for treating amyotrophic lateral sclerosis (ALS).

According to Javier San Martin, M.D., Chief Medical Officer at Athira, the preclinical data for ATH-1105 is promising. The data indicates that the drug could potentially improve motor function, preserve nerve health, and extend life expectancy in mouse models of ALS. Dr. San Martin expressed optimism about the ongoing development of this therapeutic candidate, which could be a significant breakthrough for ALS patients who have limited treatment options.

Mark Litton, Ph.D., President and CEO of Athira, echoed this sentiment. He highlighted the robust preclinical data showing ATH-1105’s neuroprotective effects, such as reducing plasma neurofilament light chain (NfL) levels, an established biomarker of neurodegeneration in ALS. Dr. Litton emphasized that by modulating the HGF system, ATH-1105 could potentially prevent or slow the progressive decline in motor and nerve function, reduce inflammation, and preserve body weight, thereby extending survival for ALS patients.

The Phase 1 clinical trial, which is double-blind and placebo-controlled, plans to enroll up to 80 healthy volunteers. The trial will involve single and multiple oral ascending doses of ATH-1105 to determine the drug’s safety and tolerability, as well as its pharmacokinetic profile. The trial is expected to be completed by the end of 2024.

ATH-1105 is a next-generation, orally administered small molecule drug candidate specifically being developed for ALS treatment. In preclinical models, ATH-1105 has shown significant benefits, including increased survival rates, enhanced motor and nerve function, and reduced peripheral nerve demyelination and axon degeneration. It also showed improvements in neurodegeneration and inflammation.

Athira Pharma, headquartered in the Seattle area, is a late clinical-stage biopharmaceutical company dedicated to developing small molecules that restore neuronal health and slow neurodegeneration. The company aims to change the course of neurological diseases through its pipeline of therapeutic candidates that modulate the neurotrophic HGF system. This includes fosgonimeton, which is currently being evaluated for mild-to-moderate Alzheimer’s disease in the Phase 2/3 LIFT-AD trial, with topline data expected in the second half of 2024.

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