Neurotech International has received Human Research Ethics Committee (HREC) approval to extend a Phase I/II clinical trial of its NTI164 cannabinoid drug candidate in autism spectrum disorder (ASD) by another 52 weeks.
The extension was based on requests from the trial’s lead investigator Professor Michael Fahey as well as from patients and their caregivers.
Professor Fahey said: “This second long-term extension to our core clinical program, which commenced in mid-2022 and reported 52-week safety and efficacy data in March 2023, reflects the significant progress my patients have made, and their caregivers’ strong desire to continue treatment over the long term.
“The lack of side-effects with NTI164 and the significant clinical improvements we’ve observed in these patients necessitates a long-term treatment plan. We thank Neurotech for their continued support of our early study patients and we look forward to the results of our larger double-blind, placebo-controlled Phase II/III clinical trial in ASD.”