Neurizon Submits FDA Response to Progress NUZ-001 Toward ALS Trial Participation

Neurizon Therapeutics Limited (ASX: NUZ) has submitted a formal response to the U.S. FDA to address the clinical hold on its Investigational New Drug (IND) application for NUZ-001, the company’s lead therapy candidate for amyotrophic lateral sclerosis (ALS). The Clinical Hold Complete Response (CHCR) includes bridging pharmacokinetic (PK) data from 28-day studies in rats and dogs, providing comprehensive animal exposure data requested by the FDA to support safety margins for NUZ-001 and its sulfone metabolite.

The newly submitted data demonstrated more than tenfold safety margins based on projected human plasma exposure and supported confidence in dose selection and tolerability. This milestone keeps Neurizon on track to join the HEALEY ALS Platform Trial in Q4 CY2025, pending regulatory clearance. FDA review is now underway, with a decision expected within 30 calendar days. CEO Dr. Michael Thurn noted this submission significantly de-risks NUZ-001's regulatory pathway, reinforcing Neurizon’s commitment to delivering innovative ALS treatments.

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