Neurizon Therapeutics Limited (ASX: NUZ & NUZOA; OTCQB: NUZTF), an Australia-based clinical-stage biotech company, announced on Thursday that that the Sean M. Healey & AMG Centre for ALS at Mass General Brigham has received clearance from the US Food and Drug Administration (FDA) to proceed with Neurizon's NUZ-001 regimen in the HEALEY ALS Platform Trial (ClinicalTrials.gov identifier: NCT04297683) following completion of the FDA's 30-day review.

Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease that affects nerve cells in the brain and spinal cord resulting in a loss of muscle control.

The FDA's acceptance of the protocol amendment allows the commencement of clinical activities under the Sean M. Healey & AMG Center for ALS Investigational New Drug (IND). The first patients are expected to be enrolled early in 2026.

The HEALEY ALS Platform Trial, a multicentre, double-blind, placebo-controlled, adaptive trial for ALS, has been developed in partnership with the Network of Excellence for ALS (NEALS).