Neurotech International (ASX:NTI) has announced positive results from its recently completed 28-day Good Laboratory Practice (GLP) oral toxicology studies evaluating its lead drug candidate NTI164.
The company said the 8-day GLP-compliant repeat-dose toxicity studies were conducted to support the regulatory development of NTI164. The studies were conducted in both Sprague-Dawley rats (total n=116) and Beagle dogs (total n=42).
Animals received twice-daily oral dosing across low, mid, and high doses, followed by a 14-day recovery period.
The company said NTI164 was well tolerated in both species, with no systemic or organ-specific toxicities attributed to the test article. It said the absence of adverse findings across clinical pathology, histopathology, and neurobehavioral assessments highlights the formulation’s favourable safety profile.
Neurotech said the data establishes the nonclinical safety foundation required for investigational new drug submissions and support global regulatory filings with regulators globally. The study’s GLP design and use of two regulatory-relevant species ensure broad acceptability across jurisdictions.
CEO and managing director Dr Anthony Filippis said, "We are extremely encouraged by these robust safety findings, which mark a crucial step in our regulatory and clinical development pathway. The positive outcomes of this toxicology study provide a solid foundation for advancing NTI164 into longer-term toxicity studies, as required by the FDA and TGA. We look forward to progressing NTI164 rapidly into the next stages of clinical development and regulatory submissions, while continuing our focus on commercial opportunities for the business."
