Clinical-stage biopharmaceutical development company Neurotech International (ASX: NTI) continues to make positive progress with 11 autism spectrum disorder (ASD) patients who were part of the company’s world-first Phase I/II clinical trial.
The trial is examining the daily use of Neurotech’s proprietary broad spectrum cannabinoid drug therapy, NTI164 out to 52 weeks of treatments, as initially announced in March 2023.
All patients have now crossed 90 weeks of daily oral therapy with NTI164. Neurotech is pleased to report that NTI164 continues to exhibit an exceptional safety and tolerability profile, with all patients showing stable blood chemistries and normal liver and kidney function over 90 weeks. The company has received qualitative feedback from parents/caregivers on their child’s ASD, as quoted below.
“We are so privileged to be a part of a revolutionary study that has enabled our child to participate in everyday activities which would have been very stressful and almost impossible to do in the past. To be able to participate in school sports and camp is something we never imagined we could achieve. We are very grateful,” a parent of one paediatric participant who has continued treatment past 90 weeks, said.
Professor Michael Fahey, Head of the Paediatric Neurology Unit at Monash Medical Centre, Director of Neurogenetics and Chief Investigator of the NTI164 Phase I/II Trial said he is delighted with the progress of the patients under this long term extension to the original Phase I/ll clinical trial, which sought to examine the safety and efficacy of NTI164 following 30 days of daily oral therapy.
“To have 11 patients still on treatment past 90 weeks is testament to the durable responses we have seen in our patients coupled with a remarkable safety profile of this intervention in Level 2 and 3 autism patients. We therefore eagerly await the results of the double-blind, placebo-controlled Phase II/III clinical trial to confirm these earlier clinical findings."
Dr Thomas Duthy, Executive Director of Neurotech, said the landmark clinical trial continues to demonstrate the excellent durability of NTI164 and importantly no significant safety concerns have arisen beyond the original 52 week analysis undertaken and reported by Neurotech.
“In our view, this updated safety analysis underscores the potential for NTI164 as a long term, chronically administered therapeutic agent in the treatment of ASD without the safety and side effects observed in approved therapies that restrict certain behaviours, particularly aggression and irritability in paediatric patients.
“NTI164 has demonstrated in a statistical manner clinically significant improvements in standardised ASD scales relating to global improvement, severity of illness, socialisation and adaptive behaviour out to 52 weeks of treatment.”