NIH Funds Healey Center Access Program for NUZ-001

Neurizon Therapeutics Limited (ASX:NUZ) has advised that the Sean M. Healey & AMG Center for ALS at Mass General Brigham has been awarded a multimillion-dollar, multi-year grant from the US National Institutes of Health to conduct an Expanded Access Protocol with Neurizon's lead investigational therapy NUZ-001 in people living with amyotrophic lateral sclerosis. The program, NIH Project Number 1U01NS153995-01, is expected to provide up to 200 people living with ALS who are otherwise ineligible to participate in clinical trials with access to NUZ-001 for up to 96 weeks. The Healey & AMG Center will be the prime recipient of the grant, with Neurizon receiving funding as a subawardee. Neurizon will serve as regulatory sponsor, with the protocol conducted under its investigational new drug application, and will be responsible for supplying NUZ-001, while the Healey & AMG Center leads clinical and operational execution including site activation, participant recruitment and data collection.

Neurizon said the program is fully funded through the NIH award, which provides for drug supply, manufacturing and specified regulatory, safety monitoring and operational costs associated with the company's participation, and that it is positioned to support the additional demand through its existing drug supply and long-term supply agreement with Elanco Animal Health Incorporated. The protocol will run in parallel with Regimen I of the Phase 2/3 HEALEY ALS Platform Trial, in which NUZ-001 is being evaluated in approximately 250 participants, and will continue beyond topline results, expected late in the second quarter of calendar 2027, contingent on a positive trial outcome. The program is expected to be conducted through about 20 physical ALS clinical trial sites and a national virtual study site, which are planned to provide potential access across 50 US states, and will collect safety and tolerability data together with survival, ALS-specific functional and respiratory measures including ALSFRS-R and slow vital capacity, patient-reported outcomes and exploratory biomarkers. Start-up activities are underway and, subject to completion of the required regulatory, site activation and operational processes, participant enrolment is targeted to commence by the first quarter of calendar 2027. Neurizon states that NUZ-001 is an investigational product and is not approved for commercial use in any jurisdiction.