Neurotech’s low-level THC drug, NTI-164, has delivered positive results after a year-long study of children with Autism Spectrum Disorder (ASD).
The company said 11 children in the phase I/II trial showed “significant benefit across a large number of clinically validated assessments” after 52 weeks.
The trial was carried out at Monash Children’s Hospital in Melbourne with 14 patients aged between 8 and 17. All suffered from level two or three ASD.
The study showed a 30% improvement from moderately ill to borderline or mildly ill, with 10 patients found to be “much improved” or “very much improved”. The drug was also well tolerated with “excellent” safety data.
Neurotech is conducting a larger phase II/III double-blind, placebo-controlled trial later this year.
Emyria’s phase 3 clinical trial examining the effects of low-dose CBD on symptoms of psychological distress is on track to be completed at the end of July as the company revealed 50 patients have already been dosed.
A further 83 are waiting for final eligibility assessment with 1,830 registered for pre-screening.
The company’s randomised, double-blind, placebo-controlled study will form the bedrock of its attempts to register an over-the-counter product with the Therapeutic Goods Administration.
The synthetic CBD capsule – EMD-RX5 – was developed by Emyria based on real-world data collected from 8,000 patients who attended its clinics.
EMD-RX5 targets mild stress and anxiety in patients with a chronic health condition, symptoms which affect 15% of Australia’s adult population, the firm said.
InhaleRx has received ethics approval to begin a phase I clinical trial of its novel inhaled cannabinoid formulation IRX211 for complex regional pain syndrome.
The trial, involving four cohorts of eight participants, will investigate the safety and pharmacokinetics of IRX211 versus a placebo.
It will be managed by contract research organisation Ingenu with patient recruitment set to get underway in May, and batch manufacturing due to begin next month.
As well as demonstrating the drug-device combination’s safety, the trial will aim to identify the best dose for a phase II trial.
InhaleRx chief executive officer Darryl Davies said: “The unique design of this device-drug combination will allow for patients to have a rapid onset solution to assist with managing breakthrough pain episodes.”