Neurotech International has announced positive results from a 15-patient, Phase I/II clinical trial of its broad-spectrum cannabinoid drug therapy NTI164.
The trial tested the efficacy and safety of the drug in children diagnosed with Paediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal Infections (PANDAS) and Paediatric Acute-Onset Neuropsychiatric Syndrome (PANS).
The company said treatment with NTI164 resulted in statistically significant improvements in symptoms associated with PANDAS/PANS after 12 weeks of daily therapy.
The trial met its key primary endpoints of anxiety and depression, with a 30% improvement overall and an 18% improvement in severity of illness. No serious adverse events were recorded.
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 already shown 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.”