Avecho Biotechnology has received ethics approval for a Phase III clinical trial testing its low-dose CBD soft-gel capsule for insomnia after submitting amendments to the TGA in December 2023.
The firm said the approval includes measures to streamline and enhance trial efficiency, “further separating the methodology away from that employed in unsuccessful Phase III trials for CBD in the treatment of insomnia in Australia to date”.
New trial sites have also been added, with a total of five to be used in Melbourne, Sydney, the Central Coast, Brisbane and Perth.
CEO Dr Paul Gavin said: “We are very pleased to complete one of the final steps in our Phase III trial program prior to commencement, with the formal approval of changes that will allow for a more efficient study.
“In addition to this, we’ve continued preparations with our team of clinical trial providers, finalised the key manufacturing elements, and had constructive dialogue with the TGA.
“We expect that all of this sets a strong foundation for what will be the largest and most robust Phase III CBD study in Australia thus far. We are now excited to start.”
The study will test Avecho’s oral CBD TPM-enhanced soft-gel capsule for the treatment of insomnia, targeting enrolment of 519 patients across three treatment groups to compare nightly CBD doses of 75 and 150mg CBD with placebo over an eight-week dosing period.
Recruitment for the trial is on track to start this month.
