Neurizon Therapeutics Limited (NUZ.AX), a late-stage clinical biotechnology company, announced the execution of a strategic long-term supply agreement with Elanco Animal Health for Monepantel in developing its lead asset NUZ-001 for Amyotrophic Lateral Sclerosis (ALS).
The deal follows a global license agreement previously executed between the parties to develop NUZ-001 as a potential therapy for ALS and other neurodegenerative diseases.
The agreement provides Neurizon long-term access to Elanco's GMP monepantel, which is the active ingredient in NUZ-001. NUZ-001 is an investigational oral therapy containing monepantel, an anthelmintic drug previously approved for use in sheep and cattle to control gastrointestinal nematodes. The drug has demonstrated an effective inhibition of the mTOR signaling pathway and is being repurposed as a potential neurodegenerative drug. NUZ-001 is currently being evaluated in the Phase 2/3 HEALEY ALS global platform trial.
The agreement is being executed with an initial five-year term and includes provisions relating to forecasting, production scheduling, and supply. Details of the first two supplies were provided, with Neurizon retaining the rights to defer further supply based on future regulatory approvals.
A separate quality agreement allocates responsibility for GMP manufacturing, quality control, batch release, and related quality regulatory matters, while commercialisation remains subject to clinical development, regulatory approval, and future outcomes.
NUZ.AX is currently trading on the Australian Securities Exchange at AU$0.07, up 7.94%.
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