Neurotech International advances clinical research

Neurotech International (ASX:NTI), a biopharmaceutical company focused on pediatric neurological disorders, has received approval to start a pharmacokinetic study of its drug NTI164. This study will be conducted at CMAX Clinical Research in Adelaide and is crucial for fulfilling regulatory requirements from authorities like the US FDA and Australian TGA. The study is scheduled to begin this quarter, with results expected in early 2025.

Neurotech's strategic roadmap and goals

Neurotech International has taken a crucial step by securing approval to initiate a pharmacokinetic study of NTI164 in healthy adults. This study aims to gather data on the drug's metabolism and excretion, vital for regulatory approvals in the US and Australia. The study involves two parts, with different dosing regimens, and will conclude by early 2025. Neurotech's ongoing research and trials in pediatric neurological disorders, including ASD and other syndromes, highlight its commitment to advancing cannabinoid-based therapies. This development aligns with the company's goal of meeting international regulatory standards, potentially leading to future drug approvals and commercialization.

Executive insights on PK study approval

Receiving HREC approval is a significant milestone for Neurotech, as this PK study is essential for our global regulatory strategy. It is a key step towards meeting the documentation requirements for IND approval and progressing through the accelerated provisional application pathway.