Neurizon Therapeutics (ASX:NUZ) has updated investors on its ongoing engagement with the US FDA on lifting the clinical hold on the company's investigational new drug application for NUZ-001.
The FDA imposed the clinical hold in February. It requested additional animal exposure data to assess the adequacy of systemic exposure to NUZ-001 during clinical studies undertaken.
Neurizon said it has communicated with the FDA to seek clarification on the requirements for lifting the clinical hold on NUZ-001. It has submitted a formal request for advice detailing two short-term, low-cost pharmacokinetic (PK) studies necessary to lift the clinical hold. The FDA indicated that it would respond formally within 60 days.
The PK studies are expected to take approximately four months from commencement to completion and include study start-up, the 28-day study treatment period, data analysis, and reporting. The initiative is expected to cost between $400,000 to $600,000.
"The decision to proactively undertake the additional studies prior to the pending formal response from the FDA follows extensive engagement between the Board, management, and the Company’s scientific and regulatory advisors," said Neurizon.
Managing Director and CEO Dr Michael Thurn said, “The decision to undertake two pharmacokinetic studies follows the ongoing review of our correspondences with the FDA to date, as well as close consultation with the Company’s scientific and regulatory advisors. The two studies, which are anticipated to be completed in around four months, are expected to generate additional animal exposure data in line with the FDA’s straightforward request to date to lift the clinical hold.
“Undertaking these studies prior to the receipt of a formal response from the FDA highlights the Company’s proactive approach to satisfying the regulator’s request and our ongoing commitment to advancing NUZ-001 as an effective potential treatment for ALS and other neurodegenerative diseases. The timely execution of these studies will allow NUZ-001 entry into the HEALEY ALS Platform Trial during the second half of CY2025. We look forward to providing further updates to shareholders on the commencement of these studies.”