US Patent granted for NUZ-001
Released
Released
Announcement PDF
Neurizon Therapeutics Limited
ABN 35 094 006 023
www.neurizon.com
US Patent granted for NUZ-001 for the treatment of Neurodegenerative Diseases
Highlights:
Patent granted by the USPTO covering the use of Neurizon’s lead drug candidate, NUZ-001, in
neurodegenerative diseases and cancer
Granted patent provides specific protection for NUZ-001 and structurally related compounds used in treatments
for mTOR pathway-related diseases in the US market until 2039
Considerably strengthen Neurizon’s commercial potential and provides a strong framework for any future
licensing negotiations
Patent grant follows FDA Orphan Drug Designation (ODD) for NUZ-001 in May 2024, further enhancing the
Company’s IP estate and market position for NUZ-001 as the clinical trial pipeline advances
5 February 2025 – Melbourne, Australia: Neurizon Therapeutics Limited (ASX: NUZ & NUZOA) (“Neurizon” or “the
Company”), a clinical-stage biotech company dedicated to advancing treatments for neurodegenerative diseases,
is pleased to confirm it has received an Issue Notification from the United States Patent & Trademark Office (USPTO)
informing the grant of a ‘method of use’ patent in connection with its lead amyotrophic lateral sclerosis/motor
neurone disease (ALS/MND) drug candidate, NUZ-001.
In December 2023, Neurizon was granted an expedited review by the USPTO after submitting a petition to make
special (PTMS). The granted patent pertains to a Neurizon-owned IP covering the ‘method of use’ of NUZ-001 in
effective doses to treat mTOR pathway-related diseases, including ALS/MND, along with multiple forms of other
neurodegenerative diseases, in particular Alzheimer’s disease, Huntington’s disease and Parkinson’s disease, and
cancer. The patent protection runway for NUZ-001 and structurally related compounds for neurodegenerative
diseases and cancer in the US now extends to 2039.
It follows the receipt by Neurizon of Orphan Drug Designation (ODD) status from the United States (US) Food and
Drug Administration (FDA) for its NUZ-001 treatment in May 2024 (refer ASX Announcement 17 May 2024). Along
with the ODD designation, the grant of this patent strengthens the development, commercialisation potential and
market opportunity for NUZ-001 by providing protection against generic competition in the US.
The US patent was issued on 4 February 2025, with patent number 12,213,957.
Managing Director and Chief Executive Officer, Dr Michael Thurn said: “We are pleased to confirm the expedited
grant of this important patent in the US. This comes at a critical juncture for the Company, as we ramp up our
product commercialisation strategy in the US. We are confident that obtaining this US patent protection
significantly strengthens our market positioning and provides a strong framework for future licensing negotiations.
The patent application is still under review in all other major regulatory jurisdictions worldwide. We look forward
to reporting additional grants in the near future.”
-ENDSThis announcement has been authorized for release by the Board of Neurizon Therapeutics Limited.
Level 4, 96-100 Albert Road, South Melbourne, VIC 3205 Tel: +61 3 9692 7222
Neurizon Therapeutics Limited
ABN 35 094 006 023
www.neurizon.com
For further information, please contact:
Dr. Michael Thurn
Managing Director and Chief Execufive Officer
Neurizon Therapeufics Limited
enquiries@neurizon.com
+61 (3) 9692 7222
Lidija Damjanovic
Head of Markefing and Corporate Affairs
Neurizon Therapeufics Limited
lidija@neurizon.com
+61 (0)425 700 504
Released through: Henry Jordan, Six Degrees Investors Relations, +61 (0) 431 271 538
About Neurizon Therapeutics Limited
Neurizon Therapeutics Limited (ASX: NUZ) is a clinical-stage biotechnology company dedicated to advancing
treatments for neurodegenerative diseases. Neurizon is developing its lead drug candidate, NUZ-001, for the
treatment of ALS, which is the most common form of motor neurone disease. Neurizon’s strategy is to accelerate
access to effective ALS treatments for patients while exploring NUZ-001’s potential for broader
neurodegenerative applications. Through international collaborations and rigorous clinical programs, Neurizon is
dedicated to creating new horizons for patients and families impacted by complex neural disorders.
Neurizon Investor Hub
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announcement or other aspects concerning Neurizon.
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hftps://investorhub.neurizon.com
Level 4, 96-100 Albert Road, South Melbourne, VIC 3205 Tel: +61 3 9692 7222
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