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Highlights
- Neurotech initiates a new study following FDA decision.
- Focus is on NTI164's pharmacokinetics in healthy adults.
- Study results expected by the first quarter of 2025.
Neurotech (ASX:NTI) has moved forward with a new baseline data study for its NTI164 drug after facing a setback from the U.S. Food and Drug Administration (FDA). The company is addressing concerns raised by the FDA while demonstrating its commitment to progressing the development of NTI164.
Earlier in October, Neurotech disclosed that its application for orphan drug status had been declined. This status, typically granted to treatments targeting rare conditions, offers advantages such as tax credits, lower fees, and marketing exclusivity. However, the FDA determined that the conditions NTI164 aims to address—Paediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal Infections (PANDAS) and Paediatric Acute-Onset Neuropsychiatric Syndrome (PANS)—did not meet the criteria for rarity.
The FDA also cited concerns about the quality of data submitted, giving Neurotech a year to respond. In response, the company has announced a pharmacokinetic (PK) study to strengthen its data. The study will examine how the body metabolizes and excretes NTI164, addressing a key requirement for regulatory approvals in both the U.S. and Australia.
The PK study is set to be conducted at CMAX Clinical Research in Adelaide. Neurotech has stated that this step aligns with global regulatory requirements for Investigational New Drug (IND) applications and approval pathways.
Dr. Thomas Duthy, Executive Director at Neurotech, emphasized the importance of the study, noting that NTI164 has already demonstrated long-term safety and efficacy in treating neurological disorders in paediatric patients. He added that conducting a PK study is a critical step in meeting the requirements of health authorities such as the FDA and Australia’s Therapeutic Goods Administration (TGA).
The company aims to use the study’s findings to support its accelerated provisional application pathway for the TGA. Neurotech has confirmed that the study will commence this quarter, with results anticipated in the first quarter of 2025.
This study marks a significant step in ensuring the viability of NTI164 for treating paediatric neurological conditions. While addressing regulatory hurdles, Neurotech continues to solidify its position in developing innovative treatments for complex disorders.
