Neurizon secures ethics approval for ALS liquid study

Neurizon Therapeutics (ASX:NUZ) has secured formal ethics approval from the Bellberry Human Research Ethics Committee to commence a Phase 1 clinical study of its NUZ-001 oral liquid formulation.

The regulatory milestone represents a strategic effort to enhance treatment accessibility for patients battling amyotrophic lateral sclerosis, a condition where progressive dysphagia—or swallowing difficulty—often hinders traditional tablet administration.

The upcoming Australian-based study will involve 32 healthy volunteers in a randomised, four-arm trial designed to compare the pharmacokinetic profile, safety, and tolerability of the liquid formulation against the existing tablet form under various dietary conditions.

Beyond physiological data, the trial will assess the liquid’s palatability and explore key biomarkers, with initiation slated for Q3 2026 and completion expected by the year's end.

This formulation programme runs parallel to Neurizon’s participation in the prestigious HEALEY ALS Platform Trial in the United States, where NUZ-001 is undergoing Phase 2/3 evaluation.

Preclinical data have already demonstrated the candidate's ability to penetrate the blood-brain barrier and stimulate neuronal protein clearance pathways essential for neuroprotection.

To support these clinical ambitions, the company recently secured $2.7 million in capital through a shortfall placement.

While navigating a leadership transition following the departure of CEO Dr Michael Thurn, interim executive chair Sergio Duchini remains focused on maintaining this clinical momentum, ensuring that the transition to more patient-friendly delivery systems remains a core priority for the firm’s development pipeline.

At the time of reporting, Neurizon Therapeutics’ share price was $0.070.