AUS
NZ
UK
CA
USA
IND
Highlight
- Neurizon submits a request to the FDA for clarification on pharmacokinetic studies to lift the clinical hold on NUZ-001.
- The FDA is expected to respond within 60 days, as Neurizon proactively starts the studies.
- The completion of these studies will support clinical development and potential regulatory approval.
Neurizon Therapeutics, a clinical-stage biotech company (ASX:NUZ) focused on neurodegenerative diseases, has recently submitted a formal request to the United States Food and Drug Administration (FDA) for guidance on pharmacokinetic (PK) studies required to lift the clinical hold on its Investigational New Drug (IND) application for NUZ-001. After the FDA requested additional animal exposure data, Neurizon swiftly moved to seek clarity on the necessary studies.
The FDA has assured that a formal response to Neurizon’s request will be provided within the next 60 days. In anticipation of this feedback, Neurizon has chosen to proactively initiate the PK studies within the coming weeks, demonstrating its commitment to advancing NUZ-001 while adhering to regulatory requirements.
According to Neurizon, these PK studies are projected to last approximately four months, encompassing various phases such as startup, a 28-day treatment period, and subsequent data analysis and reporting. The estimated cost for these studies ranges from $400,000 to $600,000, which is eligible for a rebate under the Australian government’s R&D Tax Incentive Scheme.
Dr. Michael Thurn, the Managing Director and CEO of Neurizon, underscored the strategic decision to embark on these studies promptly. Following thorough review and consultation, the company is set to generate the FDA-required data, reinforcing its dedication to developing NUZ-001 as a promising treatment option for amyotrophic lateral sclerosis/motor neurone disease (ALS/MND) and related conditions.
The additional PK data obtained through these efforts will serve to enhance the ongoing clinical development of NUZ-001, paving the way for future regulatory submissions. The company aims to ensure the entry of NUZ-001 into the Healey ALS Platform Trial by the latter half of CY2025, reflecting its proactive stance in fulfilling the FDA's straightforward request.
