U.S. FDA lifts the Clinical Hold on NUZ‑001, Neurizon®’s lead investigational therapy for ALS
Clears the way for entry into the HEALEY ALS Platform Trial expected to commence in Q4 CY2025
IND supported by robust preclinical safety data and comprehensive manufacturing and quality information from the previously signed Elanco licensing agreement
Expedites NUZ-001 as a platform molecule with pipeline expansion potential for other neurodegenerative diseases
Positions Neurizon for accelerated regulatory pathways and future partnering opportunities
FDA has completed their review of the Neurizon NUZ-001 regimen to the HEALEY ALS Platform Trial Master Protocol
This marks the official entry of NUZ-001 as Regimen I in the HEALEY ALS Platform Trial
Next steps include obtaining single IRB approval, site initiations and clinical start-up activities ahead of commencement of patient enrollment expected early in 2026
Milestone strengthens Neurizon’s pathway toward advancing a potential new treatment for ALS