Neurizon Therapeutics (ASX:NUZ) reports progress across key clinical and regulatory activities for its lead program, NUZ-001, targeting the treatment of amyotrophic lateral sclerosis (ALS).
The company said that following recent formal interactions, the US FDA has provided written feedback confirming procedural alignment with its strategy to lift the clinical hold for NUZ-001. It stated that the regulatory feedback outlines the FDA's acceptance of its strategy of conducting two preclinical pharmacokinetic (PK) studies to address the clinical hold for NUZ-001, thereby enabling continued momentum towards initiating the HEALEY ALS Platform Trial.
Neurizon said it has already completed the two necessary PK studies ahead of schedule. "The treatment phase of both studies has been successfully completed, along with the analysis of blood samples, and the study reports are being finalised," it said.
Neurizon anticipates submitting a complete response, containing data from these PK studies, to the FDA in the coming weeks as part of the formal hold resolution process.
Neurizon Managing Director and CEO Dr Michael Thurn said, “We are delighted to receive written confirmation from the FDA affirming our strategy to resolve the clinical hold for NUZ-001. By proactively progressing and completing the required PK studies ahead of schedule, we’ve maintained strong momentum and demonstrated our commitment to advancing NUZ-001 with urgency and scientific precision. We are well-positioned to submit the Complete Response in the coming weeks and anticipate that the clinical hold will be lifted in August 2025. We are focused on achieving key milestones that will enable Neurizon’s active participation in the HEALEY ALS Platform Trial later this year.”