Athira Pharma to Present Data from First-in-Human Phase 1 Clinical Trial of ATH-1105 at the 4th Annual ALS Drug Development Summit

Core Insights - Athira Pharma, Inc. announced favorable results from a Phase 1 clinical trial of ATH-1105, indicating a good safety and tolerability profile, which supports its continued development for treating ALS [1][5][3] - The company is on track to initiate a clinical trial in ALS patients by late 2025 [1][3] Group 1: ATH-1105 Overview - ATH-1105 is a novel, orally available small molecule designed to modulate the neurotrophic HGF system for potential treatment of neurodegenerative diseases, including ALS [2] - The Phase 1 trial involved 80 healthy volunteers and evaluated both single and multiple ascending doses of ATH-1105, completed in November 2024 [5] Group 2: Clinical Trial Results - The Phase 1 trial demonstrated a favorable safety profile and good tolerability in healthy volunteers, supporting further clinical development [5][7] - Data from the trial showed dose proportional pharmacokinetics and CNS penetration, reinforcing the drug's potential for ALS treatment [7][8] Group 3: Future Development Plans - The company plans to present data at the 4th Annual ALS Drug Development Summit, highlighting ATH-1105's effects on ALS validated biomarkers [1][3] - Preclinical evidence supports ATH-1105's potential, showing significant improvements in nerve and motor function, inflammation biomarkers, and survival in ALS models [4]