Neurotech International has released encouraging findings from a Phase I/II clinical trial of its broad-spectrum cannabinoid drug therapy NTI164, conducted across 15 patients.
The study assessed the drug's safety and effectiveness in children diagnosed with Paediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal Infections (PANDAS) and Paediatric Acute-Onset Neuropsychiatric Syndrome (PANS).
According to the company, patients receiving NTI164 experienced statistically significant reductions in PANDAS/PANS-related symptoms over a 12-week course of daily treatment.
The trial achieved its primary endpoints relating to anxiety and depression, delivering a 30% overall improvement and an 18% reduction in illness severity, with no serious adverse events reported.
Co-principal investigator Professor Russell Dale said: "I have observed quite profound improvements in a number of my patients with NTI164, making it the first trial of its kind with a broad-spectrum cannabinoid therapy showing initial clinical utility like this with excellent safety."
President of PANS Australia and New Zealand Advocacy and Support James Fletcher also welcomed the results: "A targeted treatment for PANS in the form of NTI164 is a very exciting development indeed," he said. "Many thanks to the researchers for their work on this therapy and to the children and families who participated in the study."
NTI164 has previously demonstrated positive clinical trial results in treating paediatric Autism Spectrum Disorder.
Neurotech executive director Dr Thomas Duthy said: "Given the lack of safe and effective treatments for PANDAS/PANS, with associated distressing symptoms and significant caregiver burden, we remain very hopeful of an accelerated development plan for NTI164 to bring this therapy to market."
