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Neurizon Therapeutics (ASX:NUZ) has shared an update on its preparations for its HEALEY ALS Platform Trial – a multicentre, double-blind, adaptive study that will assess the safety and efficacy of various investigational products for treatment of amyotrophic lateral sclerosis (ALS).
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The headlining news is the HEALEY treatment period for the trial is being extended from 24 to 36 weeks to enable a longer evaluation of treatment effects.
The study will also be enriched for fast progressors, the company said, through a shift in the “show time for symptom onset,” from 36 to 24 months. On top of that, peripheral blood mononuclear cell collection has been added to aid future research and therapy development.
Neurizon also shared data showing its lead product, NUZ-001, has been slowing the decline in slow vital capacity; a key respiratory function and survival metric for ALS.
The analysis for this was undertaken by Berry Consultants, with their findings indicating SVC could be a secondary endpoint for NUZ-001.
Specifically, they found that treatment with NUZ-001 resulted in a 48% slowing in the loss of respiratory function for all 12 patients in the Phase 1 MEND Study – compared to untreated matched controls.
“Following a comprehensive review of the data from the first five completed regimens, HEALEY has implemented improvements to the HEALEY Master Protocol to maximise the potential for a positive outcome,” Neurizon’s managing director and CEO Dr Michael Thurn said after sharing the news.
“We were excited to learn about the strong correlation between reducing the respiratory function decline rate in patients treated with NUZ-001 and overall functional decline as measured by ALSFRS-R.
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“Having supporting positive secondary endpoints greatly increases the likelihood
of receiving accelerated approval.
“Over the coming months, the company will continue to work towards finalising participation in the HEALEY trial, with entry expected during H2 CY2025, which will include completing the two short-term pharmacokinetic studies required to lift the FDA’s clinical hold.”
Neurizon shares have been trading at 10.5 cents.
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