Neurizon strengthens leadership on path to commercialisation

Clinical stage neurodegenerative biotech Neurizon has strengthened its executive team as part of commercialisation efforts.

The three new appointments will enhance NUZ’s expertise as it prepares to complete regulatory requirements. Pic: Getty Images

Special Report: Neurizon Therapeutics (ASX:NUZ) has appointed three new executives as it focuses on lifting the clinical hold for NUZ-001’s IND application to facilitate entry into the HEALEY ALS Platform Trial in H2 CY2025.

• Appointments targeted at regulatory, pre-clinical, clinical and commercial development
• The appointments include Ms Kathryn Williams as chief regulatory officer, Dr Jeffrey M Brown as chief scientific advisor and Dr Chris Freitag as chief medical advisor
• Expertise to secure NUZ-001’s investigational new drug status and advance entry into HEALEY ALS Platform Trial

Neurizon has tapped seasoned regulatory affairs leader Kathryn Williams as chief regulatory officer, neuropsychiatric and neurodegenerative expert Dr Jeffrey Brown as chief scientific advisor and oncology and rare disease expert Dr Chris Freitag as chief medical advisor.

Williams is a seasoned regulatory affairs officer with more than 20 years of experience and a proven track record in securing Fast Track and orphan designations with the FDA, EMA and TGA.

Dr Freitag has held senior roles at Roche, Shire, BTG, Debiopharm over nearly 30 years, with a strong focus on oncology and rare disease.

Dr Brown has advanced multiple programs from discovery through IND-enabling studies in pain, neuropsychiatry and Huntington’s diseases and brings a deep understanding of neuropsychiatric and neurodegenerative diseases.

“These appointments come at a crucial juncture as we transition into late-stage development and gear up for commercialisation,” Neurizon managing director and CEO Dr Michael Thurn said.

“Neurizon has assembled a powerhouse team of pharmaceutical professionals and with the backing and expertise of our Board of Directors, we are exceptionally well-prepared to bring our drug to market.

“With this enhanced leadership team, we are not only poised to advance NUZ-001 but also to expand our pipeline and deliver impactful outcomes for patients with neurodegenerative diseases and for our shareholders. 

“Our confidence in achieving these goals has never been greater.”

Investigational New Drug Status

Neurizon announced last month that it was gearing up to start 2 PK studies required by the FDA to provide additional animal exposure to support NUZ-001’s IND application. 

The company said the studies were expected to take approximately four months from start to completion, including study start-up, the 28-day study treatment period, data analysis and reporting. 

The extra PK data will enable Neurizon to address the FDA’s clinical hold and allow NUZ-001 entry into the Healey ALS Platform Trial during the second half of CY2025. 

NUZ is chiefly targeting the treatment of the rare but devasting neurodegenerative disease known as Amyotrophic Lateral Sclerosis (ALS), the most common form of motor neurone disease.

An IND application allows companies to seek authorisation from the FDA to administer investigational (unapproved) drug or biological products to humans.

The designation allows clinical trials to proceed to collect safety and effectiveness data to support marketing applications for the treatments.

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 strengthens leadership on path to commercialisation