Join our daily newsletter At The Bell to receive exclusive market insights
- Avecho Biotechnology (AVE) receives ethics approval for its phase three clinical trial of its CBD softgel capsule for the treatment of insomnia
- The company will conduct the trial through a multicentre study in up to ten sites around Australia
- Avecho will enrol 540 patients across three groups, with each to receive nightly CBD doses of either 75 milligrams, 150 milligrams or a placebo over eight weeks
- The study has been designed to be of relevance to the TGA, the FDA and the EMEA — a key factor to support potential product registration in global healthcare markets
- Avecho Biotechnology shares are up 27.27 per cent to 1.4 cents at 1:00 pm AEDT
Avecho Biotechnology (AVE) has received ethics approval for its phase three clinical trial of its CBD softgel capsule for the treatment of insomnia.
The company will conduct the trial through a multicentre study in up to ten sites around Australia, with the lead site at Monash Medical Centre in Melbourne.
Avecho will enrol 540 patients across three treatment groups, with each patient to receive nightly CBD doses of either 75 milligrams, 150 milligrams or a placebo over an eight-week period.
The trial will assess the effect of the capsules on reducing insomnia severity and improving sleep efficiency, as well as on specific aspects of sleep such as time to fall asleep, time spent waking up, and anxiety.
Avecho has already established the single-dose absorption profile from its softgel capsule and will now collect blood from patients to establish the steady-state CBD concentrations after longer periods of dosing.
The study will incorporate an interim analysis after roughly 300 patients have been dosed and has been designed to be of relevance to the Therapeutics Goods Administration (TGA), the Food and Drug Administration (FDA) and the European Medicines Evaluation Agency (EMEA).
”Everything we have learnt over the last 15 years of drug development has gone into this product and this study — and it’s a watershed moment for any biotechnology company and its investors to commence a Phase III trial,” Avecho CEO 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,” Dr Gavin said.
“This has motivated the Avecho team to work strategically and methodically to design a Phase III trial that meets regulatory criteria in key markets.”
The clinical trial is scheduled to launch in the new year.
Avecho Biotechnology shares were up 27.27 per cent to 1.4 cents at 1:00 pm AEDT.
