Neurizon Therapeutics' Groundbreaking Progress in ALS Treatment

Neurizon Therapeutics' Major Step Forward for NUZ-001

Highlights:

• Positive opinion received from the European Medicines Agency for Orphan Medicinal Product Designation for NUZ-001 in the treatment of Amyotrophic Lateral Sclerosis (ALS)
• Orphan Designation grants 10 years of exclusivity in the market upon approval, alongside further regulatory benefits
• Enhances Neurizon's position to push forward with NUZ-001 for ALS patients, a challenging neurodegenerative condition

Neurizon Therapeutics Limited (ASX: NUZ & NUZOA) is thrilled to announce the receipt of a positive opinion from the European Medicines Agency (EMA) regarding their lead drug candidate, NUZ-001, aimed at treating ALS. Following this favorable opinion, the official decision by the European Commission is anticipated shortly.

The long-awaited Orphan Medicinal Product Designation (OMPD) presents Neurizon with various incentives. Notable among these are reduced regulatory fees, free protocol assistance, and, crucially, a decade-long market exclusivity in the European Union (EU). This exclusivity implies that during the designated period, no other similar medicinal products will be authorized for marketing in the same therapeutic area.

Currently, Neurizon is advancing NUZ-001 through a Phase 2/3 clinical study that is part of the HEALEY ALS Platform Trial. Patient enrolment is projected to begin in the early months of the next fiscal year. The design of this clinical study has been structured to facilitate potential early regulatory approval. The positive opinion from the EMA on the OMPD highlights the promising pathway for NUZ-001, endorsing its potential to address urgent needs faced by ALS patients worldwide.

Dr. Michael Thurn, Managing Director and CEO, commented: "Receiving a favorable opinion from the EMA for the OMPD is a pivotal achievement for Neurizon. The disease prevalence in the EU significantly surpasses that in the U.S. With the OMPD, complemented by the Orphan Drug Designation from the U.S. FDA, we have ensured market exclusivity for NUZ-001 across major global markets for ALS treatment. This acknowledgment underscores NUZ-001's potential as a vital therapeutic option for patients, while also enhancing the commercial prospects for this promising candidate. We are eager to further collaborate with the EMA and other regulatory bodies as we strive to provide innovative solutions for ALS patients."

Next Steps:

• A formal decision from the European Commission is scheduled for later this year.
• Continue discussions with the EMA and the U.S. FDA to enhance the clinical development pathway for NUZ-001.
• Finalize the preparations for the Phase 2/3 clinical study in alignment with our strategic focus on tackling neurodegenerative diseases.

This announcement represents a significant milestone authorized by the Board of Neurizon Therapeutics Limited.

For additional information, please contact:

Dr. Michael Thurn
Managing Director and Chief Executive Officer
Neurizon Therapeutics Limited
+61 (3) 9692 7222

About Neurizon Therapeutics Limited
Neurizon Therapeutics Limited (ASX: NUZ) is a biotechnology company in clinical development, focusing on introducing advanced treatments for neurodegenerative diseases. The company is dedicated to bringing its lead drug candidate, NUZ-001, to market for ALS, which is recognized as the most common variety of motor neurone disorder. Neurizon aims to improve patient access to effective ALS treatments while investigating broader applications for NUZ-001 in neurodegenerative disorders. By leveraging international partnerships and robust clinical programs, Neurizon strives to offer new possibilities for patients and families impacted by complex neural conditions.

Frequently Asked Questions

What is the significance of Orphan Medicinal Product Designation?

The Orphan Medicinal Product Designation enhances market exclusivity, incentivizing the development of treatments for rare diseases.

What does the positive opinion from the EMA signify for Neurizon?

This positive opinion positions Neurizon to continue advancing NUZ-001, providing a stronger pathway for regulatory approval and market entries.

How long is the market exclusivity for NUZ-001?

NUZ-001 will enjoy 10 years of market exclusivity in the European Union post-approval.

What is the focus of Neurizon Therapeutics Limited?

Neurizon is focused on developing innovative treatments for neurodegenerative diseases, particularly targeting ALS with its lead drug candidate NUZ-001.

When does patient enrolment for the clinical study begin?

Patient enrolment for the Phase 2/3 clinical study of NUZ-001 is expected to commence in early H1 of next year.

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