WA biotech Neurotech International wins vital ethics approval for cannabinoid drug therapy

WA biotech Neurotech International has won vital ethics approval for its cannabinoid drug therapy aimed at treating neurological disorders in children. The Nedlands-based company told the market on Monday it had received approval for its planned pharmacokinetic study — which looks at what the body does to a drug — of its lead drug candidate, NTI164. The drug is aimed at treating paediatric neurological disorders such as autism, paediatric acute-onset neuropsychiatric syndrome (PANS) and paediatric autoimmune neuropsychiatric disorders associated with streptococcal infections (PANDAS). Neurotech said the study — set to commence this quarter in Adelaide — would generate important clinical data on the metabolism and excretion of NTI164 in 12 adult participants. “Although we have demonstrated long term safety and efficacy of NTI164 in paediatric patients across three separate neurological disorders, a (pharmacokinetic) study is a requirement for global health regulators,” Neurotech executive director Thomas Duthy said. This included the US Food and Drug Administration as part of an investigational new drug approval, as well as Australia’s Therapeutic Goods Administration. Neurotech last month failed to get a so-called orphan drug designation from the FDA for the use NTI164 to treat PANDAS/PANS. The regulator believes the disorders may not be classed as rare diseases in the US. The FDA defines a rare disease as any condition that affects fewer than 200,000 patients in the US.