Neurotech International
A year-long study of children with Autism Spectrum Disorder (ASD) has returned positive results for Neurotech's low-THC drug candidate, NTI-164.
According to the company, 11 children enrolled in the phase I/II trial demonstrated "significant benefit across a large number of clinically validated assessments" over 52 weeks.
The trial was conducted at Monash Children's Hospital in Melbourne and enrolled 14 patients between the ages of 8 and 17, all of whom had level two or three ASD.
Results showed a 30% improvement from moderately ill to borderline or mildly ill, and 10 patients were rated as "much improved" or "very much improved". The drug was well tolerated and produced "excellent" safety data.
Neurotech plans to conduct a larger phase II/III double-blind, placebo-controlled trial later this year.
Emyria
Emyria's phase 3 clinical trial assessing the impact of low-dose CBD on psychological distress symptoms is on course for completion at the end of July, with the company confirming that 50 patients have already received doses.
An additional 83 patients are awaiting final eligibility assessment, while 1,830 have registered for pre-screening.
The randomised, double-blind, placebo-controlled study will underpin the company's application to register an over-the-counter product with the Therapeutic Goods Administration.
The synthetic CBD capsule — EMD-RX5 — was created by Emyria drawing on real-world data gathered from 8,000 patients who visited its clinics.
EMD-RX5 is aimed at mild stress and anxiety in patients with a chronic health condition, symptoms that affect 15% of Australia's adult population, according to the firm.
InhaleRx
InhaleRx has been granted ethics approval to proceed with a phase I clinical trial of its novel inhaled cannabinoid formulation IRX211, targeting complex regional pain syndrome.
The trial will be structured across four cohorts of eight participants and will examine the safety and pharmacokinetics of IRX211 compared with a placebo.
Contract research organisation Ingenu will manage the trial, with patient recruitment scheduled to begin in May and batch manufacturing set to commence next month.
Beyond establishing the safety of the drug-device combination, the trial is designed to determine the optimal dose ahead of 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."
