Highlights: MELBOURNE, Australia, Nov. 11, 2024 /PRNewswire/ -- Neurizon Therapeutics Limited (ASX: NUZ & NUZOA) ("Neurizon" or "the Company"), a clinical-stage biotech company advancing treatments for neurodegenerative diseases, is pleased to announce it has received notice of a positive opinion from the European Medicines Agency (EMA) for Orphan Medicinal Product Designation (OMPD) following its application for its lead drug candidate, NUZ-001, for the treatment of Amyotrophic Lateral Sclerosis (ALS). The European Commission is scheduled to issue the official decision on the Orphan Designation in December.
OMPD will offer Neurizon a range of attractive incentives for NUZ-001. These include reduced regulatory fees, free protocol assistance, and, importantly, 10 years of market exclusivity in the European Union (EU). During the exclusivity period, the EMA and the EU Member States will not accept another marketing authorisation application for a similar medicinal product in the same therapeutic indication.
Neurizon is advancing NUZ-001 through a Phase 2/3 clinical study as part of the HEALEY ALS Platform Trial, with patient enrolment expected to commence in early H1 CY2025. Our protocol regimen has been designed to support the potential for early regulatory approval. The notice of a positive opinion from the EMA on the OMPD further supports our pathway for NUZ-001, underscoring its potential to meet urgent unmet needs in ALS on a global scale.
Managing Director and Chief Execu.
