Athira Pharma, Inc. announced that it has completed the first cohort of healthy volunteers in its ongoing, first-in-human, dose escalation Phase 1 clinical study evaluating ATH-1105, an oral, small molecule positive modulator of the neurotrophic hepatocyte growth factor (HGF) system in development for the treatment of amyotrophic lateral sclerosis (ALS). The Phase 1 (NCT 06432647) double-blind, placebo-controlled trial will enroll up to 80 healthy volunteers and evaluate single and multiple oral ascending doses. The study will evaluate the safety and tolerability of ATH-1105 and will include measurement of pharmacokinetic outcomes.

Completion is expected by year-end 2024. ATH-1105 is a next-generation, orally administered, small molecule drug candidate in development for the potential treatment of ALS. In preclinical models of ALS, ATH-1105 has been shown to significantly increase survival, enhance motor and nerve function, reduce peripheral nerve demyelination and axon degeneration, and improve neurodegeneration and inflammation.