Avecho Biotechnology (ASX: AVE) has locked-in ethics approval for a phase III clinical trial of its oral cannabidiol (CBD) softgel capsule in treating insomnia – paving the way for the study to begin next year.
The upcoming study has been designed to meet guidelines of Australia’s Therapeutic Goods Association (TGA), the US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA).
Ensuring relevance to these regulatory bodies will support Avecho’s future efforts in commercialising the softgel capsule for international markets.
Avecho’s CBD softgel capsule includes its proprietary drug delivery system Tocopheryl Phosphate Mixture (TPM), which enhances the solubility and oral, dermal and transdermal absorption of drugs and nutrients.
Chief executive officer Dr Paul Gavin said it was a “watershed moment” for Avecho to begin a phase III trial.
“Everything we have learnt over the last 15 years of drug development has gone into this product and this study.”
“We are working with a trial design and host of respected professionals that will maximise the chance of success and eventual approval in multiple regions.”
Dr Gavin noted the TGA has never assessed CBD before in a submission package for pharmaceutical approvals – adding that no regulatory agency in the world has approved CBD for treating insomnia.
“This has motivated the Avecho team to work strategically and methodically to design a phase III trial that meets regulatory criteria in key markets.”
“It is hoped this will put us in a leading position for both regulatory approval and for negotiating significant commercial deals with leading international pharmaceutical companies.”
Phase III trial
The upcoming phase III trial will be undertaken at 10 sites around Australia.
Melbourne’s Monash Medical Centre will be the lead site and the study will be supervised by Associate Prof, and deputy director of Monash Health, Darren Mansfield.
All-up, 540 patients will be enrolled in the study, which will have three treatment groups to compare the nightly doses of 75mg CBD, 150mg CBD and placebo.
The dosing period will be over eight weeks and the trial will evaluate two primary endpoints – reducing insomnia severity as measured on the Insomnia Severity Index (ISI) and subjective sleep efficiency.
Meanwhile, key secondary endpoints will assess specific aspects of sleep, including time to fall asleep and time spent waking after sleep is initiated. Additional endpoints will also be examined including anxiety and other aspects of sleep.
An interim analysis of the study will be completed after about 300 patients have been dosed to conduct a powering and futility assessment.
This analysis will be used to confirm the number of patients needed to complete the study, and whether there is any effect present.
A number of international sleep experts have provided input to Avecho in designing the trial.
The study will begin next year.
