Neurizon Therapeutics (ASX:NUZ) has secured Human Research Ethics Committee approval for a Phase 1 study of an oral liquid formulation of NUZ-001, a step the company says supports the continued development of its lead candidate for amyotrophic lateral sclerosis.
The approval from Bellberry HREC clears a randomised, four-arm trial in Australia that will enrol 32 healthy volunteers to compare oral liquid and tablet formulations under fed and fasted conditions and to collect pharmacokinetic, safety and tolerability data alongside exploratory biomarker and palatability information.
The study is part of Neurizon’s broader NUZ-001 program and runs alongside the company’s participation in the Phase 2/3 HEALEY ALS Platform Trial in the United States.
Neurizon says the oral liquid formulation was developed to improve treatment accessibility and flexibility of administration as ALS progresses and swallowing difficulties increase, with the goal of supporting continuity of treatment across different stages of the disease.
Interim Executive Chairman Sergio Duchini said, "Receipt of HREC approval marks another important milestone in the advancement of the NUZ-001 development program and reflects Neurizon’s commitment to developing patient‑centred therapeutic solutions in ALS."
He continued, "The oral liquid formulation was developed in direct response to the practical challenges faced by people living with ALS, particularly as swallowing difficulties become more prominent during disease progression. In addition to supporting flexibility and continuity of treatment, the formulation is intended to improve the overall practicality of administration for patients, caregivers and clinical teams."