250 participants enrolled in less than five months from first participant dosing, representing the fastest site activation and enrolment in the HEALEY ALS Platform Trial so far
Anticipated topline efficacy and safety results for NUZ-001 now expected in late Q2 CY2027
Completion of recruitment materially de-risks execution of Neurizon's lead late-stage clinical program
Reflects strong recruitment and effective execution across the HEALEY ALS Platform Trial network
Participants now progressing through the planned 36-week randomised treatment period
MELBOURNE, Australia, 16 July 2026 /PRNewswire/ -- Neurizon® Therapeutics Limited (ASX: NUZ; OTCQB: NUZTF) ("Neurizon" or "the Company"), a late-stage clinical biotechnology company dedicated to advancing innovative treatments for neurodegenerative diseases, is pleased to advise that enrolment has been completed in Regimen I of the Phase 2/3 HEALEY ALS Platform Trial evaluating the Company's lead investigational therapy NUZ-001 for the treatment of amyotrophic lateral sclerosis (ALS).
Neurizon advises that the final participant has completed their baseline visit and commenced treatment, completing enrolment into Regimen I. Reflecting the rapid pace of recruitment, the Company now expects to report topline efficacy and safety results in late Q2 CY2027, earlier than previously anticipated.
Completion of enrolment, together with the earlier anticipated timing of the topline results readout, further demonstrates the continued advancement of the late-stage clinical development program for NUZ-001 for the treatment of ALS. Regimen I completed enrolment in less than five months from first participant dosing, becoming the fastest regimen to activate sites and complete enrolment in the HEALEY ALS Platform Trial, even after the planned sample size expansion from 160 to 240 participants in response to strong recruitment momentum.
This achievement reflects the strength of recruitment across the HEALEY ALS Platform Trial network, one of the world's leading ALS clinical trial initiatives, the operational efficiencies introduced under the trial's next generation master protocol, and the commitment of investigators, research coordinators and clinical site teams across the United States.
Neurizon sincerely acknowledges every person living with ALS and their families who has chosen to participate in this research, recognising that their commitment is fundamental to advancing clinical research and the development of potential new treatment options for the ALS community.