Neurizon Therapeutics Ltd (ASX:NUZ, OTC:NUZTF, FRA:ECQ0) has reached a key milestone in the HEALEY ALS Platform Trial, with more than half of participants in the study’s NUZ-001 treatment arm now dosed ahead of schedule, reinforcing confidence in the program’s timeline and recruitment momentum.
The company said 129 of the planned 240 participants in Regimen I of the HEALEY ALS Platform Trial had received treatment as of 9 June 2026, while 167 participants had been assigned to the study arm. Recruitment is continuing across 78 activated clinical trial sites in the United States.
“Surpassing the 50% dosing milestone in Regimen I represents another important achievement for the NUZ-001 program and provides further evidence of the strong execution capabilities of the HEALEY ALS Platform Trial network. Importantly, this milestone has been achieved shortly after the expansion of the study from 160 to 240 participants, highlighting the continued enthusiasm from investigators, clinical sites and the ALS community, as well as the efficiency of the platform in progressing patients through recruitment, screening, randomisation and treatment," interim executive chairman, Sergio Duchini said.
"The pace of enrolment and dosing continues to exceed our original expectations and reinforces our confidence in the operational timelines for the study. With more than half of participants now dosed, we believe Neurizon remains well positioned to deliver a robust dataset that has the potential to support future regulatory, partnering and commercial opportunities for NUZ-001. We look forward to maintaining this momentum as we continue advancing towards full enrolment, last patient dosing and the release of topline results.”
Expansion supports larger clinical dataset
The milestone follows a recent expansion of Regimen I from 160 to 240 participants after recruitment rates exceeded expectations and no concurrent regimen was recruiting during the same period. According to Neurizon, the larger study population is expected to generate a more comprehensive dataset while preserving the original statistical assumptions used for the trial’s primary efficacy analysis.
The HEALEY ALS Platform Trial is a Phase 2/3 adaptive, double-blind, placebo-controlled study run by the Sean M. Healey & AMG Center for ALS at Mass General Brigham in partnership with the Network of Excellence for ALS. The platform is designed to accelerate the development of new therapies for amyotrophic lateral sclerosis (ALS), the most common form of motor neurone disease.
Neurizon said the pace of recruitment and dosing continues to exceed original expectations, supporting its outlook for last participant dosing in the second quarter of calendar 2027 and the release of topline results in early Q3 2027.