Neurizon Therapeutics Ltd (ASX:NUZ) has received ethics approval from the Bellberry Human Research Ethics Committee for a Phase 1 formulation study of its NUZ-001 oral liquid treatment for amyotrophic lateral sclerosis (ALS).
The approval allows Neurizon to advance clinical work on an oral liquid version of NUZ-001, which is being developed to improve treatment access and flexibility for people living with ALS.
“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,” interim executive chairman Sergio Duchini said.
“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.”
“The advancement of the oral liquid formulation reflects Neurizon’s broader strategy to support long-term treatment accessibility and expand the potential utility of NUZ-001 across different stages of disease progression. ”
Addressing swallowing difficulties in ALS
ALS is associated with progressive impairment of speech and swallowing, known as dysphagia, which can make tablet-based treatment more difficult as the disease advances.
Neurizon said the oral liquid formulation is intended to support continuity of treatment across different stages of ALS, particularly as swallowing difficulties increase.
Study to assess safety and pharmacokinetics
The Phase 1 trial will enrol 32 healthy volunteers in Australia and will evaluate NUZ-001 oral liquid and tablet formulations under fed and fasted conditions.
The randomised, four-arm study is designed to generate pharmacokinetic, safety and tolerability data, along with exploratory biomarker and palatability data.
These results are expected to support further clinical, regulatory and commercial development of NUZ-001.
Part of broader ALS program
The formulation study sits alongside Neurizon’s broader NUZ-001 development program, including its ongoing participation in the Phase 2/3 HEALEY ALS Platform Trial in the United States.
Ethics approval marks a further step in the company’s strategy to develop NUZ-001 as a flexible treatment option for ALS patients and to build the data package required for future regulatory engagement.