HEALEY ALS Platform Trial Regimen I expands to 240 participants
Highlights: * Neurizon announces an expansion to the size of Regimen I intended to support a larger and more informative dataset, with accelerated time to topline readout and no change in funding requirements * Increase in sample size driven by enrolment rate exceeding original expectations ...
FDA Lifts Clinical Hold on NUZ-001
Highlights: * 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 ...
Neurizon Files IND Application to Support HEALEY ALS Platform Trial
Highlights: * IND application submission to the U.S. Food and Drug Administration (FDA) is a pivotal step in initiating a Phase 2/3 clinical study for NUZ-001 * The IND is a comprehensive dossier of information, including animal and human studies, pharmacokinetic analyses, toxicology studies,...
