Highlights:
- Neurizon® makes three key executive appointments: Ms Kathryn Williams as Chief Regulatory Officer, Dr Jeffrey M. Brown as Chief Scientific Advisor, and Dr Chris Freitag as Chief Medical Advisor
- Appointments to unlock Neurizon’s access to extensive regulatory affairs, preclinical and clinical development, and commercialisation experience at a pivotal time in NUZ-001’s development pathway
- Kathryn Williams is a seasoned regulatory affairs leader with over 20 years of experience and a proven track record securing Fast Track and orphan designations with the FDA, EMA, and TGA
- Dr Brown brings deep scientific understanding in neuropsychiatric and neurodegenerative diseases, advancing multiple programs from discovery through IND-enabling studies in pain, neuropsychiatry, and Huntington’s diseases currently in clinical trials
- Dr Freitag has nearly 30 years of experience in medical affairs and clinical development, having held senior roles at Roche, Shire, BTG, and Debiopharm, with a strong focus on oncology and rare diseases
- Appointments considerably enhance Neurizon’s expertise across key areas of focus and will assist with the Company’s strategy of commercialising its lead asset, NUZ-001
MELBOURNE, Australia, April 17, 2025 / Biotech Newswire / -- Neurizon Therapeutics Limited (ASX: NUZ & NUZOA) (“Neurizon” or “the Company”), a clinical-stage biotech company dedicated to advancing innovative treatments for neurodegenerative diseases, is pleased to announce that it has significantly strengthened its executive management team with three key appointments. These include Ms. Kathryn Williams as Chief Regulatory Officer (CRO), Dr Jeffrey M. Brown as Chief Scientific Advisor (CSA), and Dr Chris Freitag as Chief Medical Advisor (CMA).
These appointments provide the Company with broader expertise in regulatory affairs, clinical development and commercialisation, and will assist in accelerating Neurizon’s stated strategy to advance its lead drug candidate, NUZ-001’s clinical development pathway, secure regulatory approvals, expand the pipeline in neurodegenerative diseases and optimise future market access. The combined expertise of Ms Williams, Dr Brown, and Dr Freitag will assist in the Company’s near-term focus to lift the clinical hold for NUZ-001’s IND application to facilitate entry into the HEALEY ALS Platform Trial in H2 CY2025.
Chief Regulatory Officer – Ms Kathryn Williams:
Ms Williams is a distinguished regulatory affairs executive with over 20 years of industry experience. She has a proven track record developing and executing global regulatory strategies in major jurisdictions, including the US FDA, European EMA and Australian TGA. Ms Williams is considered a global regulatory specialist, navigating expedited approval pathways and securing orphan drug designations for rare diseases and novel therapies.
Most recently, Ms Williams held the position of Vice President of Regulatory Affairs at Clarity Pharmaceuticals Limited (ASX: CU6). During her tenure with Clarity Pharmaceuticals, she was responsible for obtaining three FDA Fast Track designations for a novel radiopharmaceutical and led multiple regulatory filings. Throughout her career, Ms Williams has held leadership positions in notable companies, including Merck, Sandoz, Sanofi and Genzyme.
The Company will leverage her extensive background in pharmaceutical regulation and health economics to ensure Neurizon’s clinical programs are well-positioned for regulatory, commercial, and reimbursement success. As CRO, she will oversee regulatory engagement, Chemistry Manufacturing Control (CMC) alignment, and quality compliance systems, while leading regulatory strategy across all development stages. Her focus will be on securing Investigational New Drug (IND) status, Fast Track, Breakthrough Therapy, and Orphan Drug designations, as well as optimising our regulatory efforts to support accelerated approval across multiple jurisdictions for NUZ-001.
Chief Scientific Advisor – Dr Jeffrey M. Brown:
Dr Brown brings extensive drug development experience, scientific leadership, and commercial acumen, in the development of new treatments for neuropsychiatric and neurodegenerative diseases. Over his two-decade career, he has overseen multiple neurology programs from early discovery through IND-enabling studies. This includes select programs in pain, neuropsychiatry, and Huntington’s diseases currently in clinical trials.
Dr Brown’s deep scientific understanding of neuropsychiatric and neurodegenerative disease pathways has led to executive leadership roles in global biopharmaceutical companies such as Amgen, Pfizer, Bristol-Myers Squib, Alexion, Wave, Voyager, and Deep genomics, managing R&D organisations, expanding pipeline and platform capabilities, and nurturing partnering and commercial discussions. His expertise in drug discovery and defining product development opportunities will be instrumental in expanding and advancing the reach of Neurizon’s therapeutic pipeline in neurodegenerative diseases. Dr Brown currently serves on the Board of Directors of the Huntington’s Disease Society of America.
Located in Boston, a supportive ecosystem for biotech companies and often referred to as a "biotech hub," Dr. Brown’s appointment expands our global presence. His established networks create new opportunities for Neurizon to collaborate with leading research institutions, access significant funding, and enhance the company’s potential for strategic partnerships and expedited commercialisation. It also maintains our strong ties with our clinical partner Massachusetts General Hospital and Sean M. Healey & AMG Center for ALS.
Chief Medical Advisor – Dr Chris Freitag:
Dr Freitag is a medical doctor with nearly 30 years of combined medical and pharmaceutical experience, with a strong focus on oncology and rare diseases. His early career in clinical practice was followed by senior roles at Roche, Shire, BTG, and Debiopharm, where he led clinical programs across biologics, small molecules, and medical devices.
He has played pivotal roles in developing and strategically positioning several successful therapies, including Rituximab, Bevacizumab, Anagrelide, Resolor, and Xevinapant. More recently, Dr Freitag has served as Chief Medical Officer or strategic advisor to several emerging biotech companies, primarily in neurodegenerative diseases, pediatric rare diseases (myopathies), and oncology.
Dr. Freitag is already a valuable member of Neurizon’s Scientific Advisory Board (SAB) and possesses intricate knowledge of the clinical safety and efficacy profile of NUZ-001. He has served as the medical monitor (MM) for Neurizon’s successful Phase 1 MEND study and is currently the MM for the Open Label Extension (OLE) study for NUZ-001, which is nearing completion. His increased involvement as CMA will significantly benefit the Company’s clinical development program for NUZ-001, ongoing trial designs, and medical affairs. Dr. Freitag's extensive experience will be crucial in guiding NUZ-001 through regulatory interactions, Point of Care considerations, and achieving regulatory approval.
Managing Director and Chief Executive Officer Dr. Michael Thurn said: “On behalf of the Board, we are thrilled to welcome Ms Williams, Dr Brown and Dr Freitag to the Neurizon leadership team. Each pharmaceutical professional brings exceptional experience, business and commercial acumen, and a shared commitment to advancing therapies that can transform the lives of patients with neurodegenerative diseases. Their collective expertise across preclinical and clinical development, regulatory affairs, scientific leadership, and commercialization strategy significantly enhances our ability to execute our mission.”
“Kathryn’s leadership in navigating regulatory pathways and securing expedited designations will be vital as we seek to advance NUZ-001 toward regulatory approval. Dr Brown’s deep understanding of the pathogenesis of neurodegenerative diseases strengthens our drug development and commercial opportunities, while Dr Freitag’s global medical affairs and pharmacovigilance experience ensures Neurizon is well positioned to execute our programs with excellence.”
“These appointments come at a crucial juncture as we transition into late-stage development and gear up for commercialisation. 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.”
This announcement has been authorized for release by the Board of Neurizon Therapeutics Limited.
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® is a registered trademark of Neurizon Therapeutics Limited
Contacts
Neurizon Therapeutics Limited
Dr. Michael Thurn
Managing Director and Chief Executive Officer
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+61 (3) 9692 7222
Lidija Damjanovic
Head of Marketing and Corporate Affairs
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+61 (0) 425 700 504
Keywords: Neurodegenerative Diseases; Leadership; Appointments and Schedules; Biotechnology; Neurizon; NUZ-001; Kathryn Williams; Jeffrey M. Brown; Chris Freitag; regulatory affairs; clinical development; commercialisation; neurodegenerative diseases; neuropsychiatric diseases; HEALEY ALS Platform Trial; ALS; medical affairs; regulatory strategy; drug development; CEO Michael Thurn; market access; clinical-stage biotech company
Source: Biotech Newswire