Ethics Approval received for Phase III Clinical Trial
Avecho Biotechnology Limited (ASX:AVE) has announced that it has now received ethics approval for our Phase III clinical trial, testing our oral CBD softgel capsule for insomnia.
We are now on track to commence the largest randomised, placebo controlled study being undertaken in Australia, to support registration of cannabidiol as an over-the-counter medicine with the Therapeutic Goods Administration (TGA).
Under the study design, which has been developed in consultations with a number of international sleep experts, patients will be enrolled across three treatment groups to compare nightly CBD doses of 75 and 150 mg CBD with placebo over an 8 week dosing period. The study will measure the effects of the treatments on reductions in insomnia severity, as measured by the Insomnia Severity Index (ISI), and subjective sleep efficiency. Additional data will be collected on other objective and subjective aspects of sleep.
Avecho CEO, Dr Paul Gavin, said:
“The TGA has never assessed CBD in a submission package for pharmaceutical approval – similarly, no regulatory agency in the world has approved CBD for this indication. 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.”