Neurizon granted US patent for lead drug to treat motor neurone and other neurodegenerative conditions

A patent has been granted in the US covering the use of Neurizon’s lead drug candidate NUZ-001 in neurodegenerative diseases and cancer.

Granting of a US patent for NUZ-001 strengthens Neurizon’s commercial potential. Pic via Getty

Special Report: Neurizon Therapeutics has achieved a key milestone with a patent granted in the US for its lead drug candidate NUZ-001 to treat amyotrophic lateral sclerosis/motor neurone disease (ALS/MND), other neurodegenerative diseases and cancer. 

• Neurizon granted US patent for lead drug NUZ-001 to treat mTOR pathway-related diseases, other neurodegenerative conditions and cancer
• The company said the US patent strengthens its commercial potential and provides a strong framework for any future licensing negotiations
• Patent grant follows FDA Orphan Drug Designation for NUZ-001 in 2024 as clinical pipeline progresses

Clinical-stage biotech company Neurizon Therapeutics (ASX: NUZ) said it had received an Issue Notification from the United States Patent & Trademark Office (USPTO) confirming the grant of a ‘method of use’ patent for NUZ-001.

The newly granted patent covers Neurizon’s proprietary method of using NUZ-001 in effective doses to treat mTOR pathway-related diseases, including amyotrophic lateral sclerosis/motor neuron disease (ALS/MND). 

The company said it also extends to multiple forms of other neurodegenerative conditions such as Alzheimer’s, Huntington’s, and Parkinson’s disease, as well as cancer.

Neurizon said the patent provides intellectual property protection for NUZ-001 and structurally related compounds in the US until 2039.

The US patent was issued on February 4 with patent number 12,213,957.

Neurizon was granted an expedited review by the USPTO in December 2023 after submitting a Petition to Make Special (PTMS) to accelerate the process of gaining a patent.

The patent follows receipt by Neurizon of Orphan Drug Designation (ODD) status from the US Food and Drug Administration (FDA) for NUZ-001 in May 2024. 

The FDA’s ODD status is designed to support the development of treatments for rare diseases affecting fewer than 200,000 people in the US.

Benefits include tax credits, grants, waived clinical trial fees, and seven years of market exclusivity upon drug approval.

Neurizon said that, along with the ODD designation, granting the patent strengthens the development, commercialisation potential and market opportunity for NUZ-001 by providing protection against generic competition in the US.

Strengthens market position

Managing director and CEO Dr Michael Thurn said granting of the US patent was an important milestone for the company. 

“This comes at a critical juncture for the company, as we ramp up our product commercialisation strategy in the US,” he said. 

“We are confident that obtaining this US patent protection significantly strengthens our market positioning and provides a strong framework for future licensing negotiations.”

Thurn said patent applications were still under review in all other major regulatory jurisdictions worldwide. 

“We look forward to reporting additional grants in the near future,” he said. 

This article was developed in collaboration with Neurizon Therapeutics, a Stockhead advertiser at the time of publishing. 

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.

Originally published as Neurizon granted US patent for lead drug to treat motor neurone and other neurodegenerative conditions