FDA Clears Neurizon's NUZ-001 for Phase 2/3 ALS Trial
Neurizon Therapeutics Limited has received a significant boost in its mission to treat Amyotrophic Lateral Sclerosis (ALS) with its lead drug, NUZ-001. The U.S. Food and Drug Administration (FDA) has lifted the clinical hold on the drug and cleared it for Phase 2/3 development.
NUZ-001 has shown promising results in an Open-Label Extension (OLE) study involving ALS patients. The drug's potential has been further validated by the FDA's decision, marking a significant milestone in Neurizon's journey. Dr. Michael Thurn, Neurizon's Managing Director and CEO, expressed gratitude to key opinion leaders and patient advocacy groups for their support.
NUZ-001 is now set to be part of the HEALEY ALS Platform Trial, expected to start in Q4 2025. Massachusetts General Hospital (MGH), which leads the trial, plans to file a protocol amendment to incorporate NUZ-001 in the coming weeks. Patient enrollment is anticipated to begin in Q4 2025.
These developments advance Neurizon's mission to accelerate patient access to innovative therapies and create long-term value for shareholders. The FDA's decision establishes a regulatory foundation for future programs, bringing hope to ALS patients and their families.
Read also:
- Dual-function mattress offers both cooling and coziness at an affordable price.
- Ontario falls short by a small margin in delivering the goal of four hours daily care for long-term care residents.
- "Thrilled response" from animal rights organization following cessation of canine testing at London, Ontario healthcare facility
- Mindfulness-Based Cognitive Therapy's Role in Alleviating Chronic Worries and Anxieties
