• Updates to HEALEY ALS Platform Trial Master Protocol to enhance potential for clinically meaningful outcome
• New data analysis confirms slow vital capacity (SVC) as a key secondary endpoint for NUZ-001
• Treatment with NUZ-001 resulted in 48% slowing in loss of respiratory function compared to untreated controls

Neurizon Therapeutics Limited (ASX: NUZ) has provided an update on preparations for entry into the HEALEY ALS Platform Trial, along with encouraging new data showing that NUZ-001 slows the decline in slow vital capacity (SVC), a key respiratory function and survival metric in Amyotrophic Lateral Sclerosis (ALS). The HEALEY ALS Platform Trial is a multicenter, double-blind, placebo-controlled, perpetual and adaptive study evaluating the safety and efficacy of multiple investigational products for ALS treatment. Updates to the Master Protocol include extending the Randomized Controlled Trial (RCT) period from 24 to 36 weeks, modifying the Inclusion Criteria to enrich the study population for fast progressors, and adding peripheral blood mononuclear cell (PBMC) collection to aid future research and therapy development. A new data analysis of SVC results from the completed Phase 1 MEND study confirmed the selection of SVC as a key secondary endpoint in the HEALEY ALS Platform Trial. The analysis showed that the estimated rate of decline for all 12 patients treated with NUZ-001 was 48% slower compared to untreated matched controls, correlating closely with the previously announced 39% slowing in the ALS Functional Rating Scale-Revised (ALSFRS-R) rate of decline. Neurizon will now finalize its Regimen Specific Appendix (RSA) under the Master Protocol for submission to the FDA as soon as the clinical hold on NUZ-001 has been lifted, with entry into the HEALEY trial expected in H2 CY2025.

Neurizon remains well placed for trial entry in H2 CY2025, which will include completing the two short-term pharmacokinetic studies required to lift the FDA's clinical hold on NUZ-001.