US Patent Extends NUZ-001 Protection to 2039, Enhancing Neurizon’s Market Position

Neurizon’s Patent Milestone

Neurizon Therapeutics Limited (ASX: NUZ) has achieved a significant intellectual property milestone with the United States Patent and Trademark Office (USPTO) granting a 'method of use' patent for its lead drug candidate, NUZ-001. This patent specifically covers the use of NUZ-001 and structurally related compounds in treating diseases linked to the mTOR pathway, including amyotrophic lateral sclerosis (ALS), other neurodegenerative diseases such as Alzheimer's, Huntington's, Parkinson's, and certain cancers.

The patent, issued on 4 February 2025 under number 12,213,957, extends Neurizon’s exclusive rights in the US market until 2039, providing a robust legal framework to protect against generic competition and underpinning the company’s commercial strategy.

Strategic Implications for Neurizon

This patent grant follows the FDA’s Orphan Drug Designation (ODD) awarded to NUZ-001 in May 2024, which already positioned the drug favorably for expedited development and regulatory incentives. Together, these developments significantly enhance Neurizon’s intellectual property estate and market positioning, particularly in the lucrative and underserved neurodegenerative disease space.

Managing Director Dr Michael Thurn highlighted the timing of the patent grant as critical, coinciding with the company’s efforts to ramp up commercialisation strategies in the US. The patent not only secures a long-term competitive moat but also strengthens Neurizon’s hand in future licensing negotiations, potentially attracting strategic partners or investors interested in the ALS and broader neurodegenerative treatment markets.

Broader Market and Clinical Context

ALS and related neurodegenerative diseases represent a significant unmet medical need globally, with limited effective treatment options. NUZ-001’s targeting of the mTOR pathway, a key regulator in cell growth and survival, offers a novel therapeutic approach that could extend beyond ALS to other debilitating conditions. The patent’s inclusion of cancer indications further broadens the potential application and commercial value of NUZ-001.

While the US patent provides a strong foothold, Neurizon’s patent applications remain under review in other major jurisdictions, which will be crucial for establishing a global market presence. The company’s ongoing clinical trials and regulatory progress will be closely watched by investors and industry observers as indicators of NUZ-001’s future commercial viability.

Looking Ahead

Neurizon’s next steps will likely focus on advancing clinical development, securing additional patent grants internationally, and exploring partnerships to accelerate market entry. The company’s Investor Hub remains a resource for stakeholders seeking updates and engagement opportunities.