Avecho Biotechnology has received ethics approval to proceed with a Phase III clinical trial of its low-dose CBD soft-gel capsule as a treatment for insomnia, following amendments submitted to the TGA in December 2023.
The company said the approval incorporates measures to improve 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".
The trial will also expand its footprint by adding new sites, bringing the total to five locations across 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 trial will evaluate Avecho's oral CBD TPM-enhanced soft-gel capsule as an insomnia treatment, with a target enrolment of 519 patients across three treatment groups. Participants will receive nightly CBD doses of either 75mg or 150mg, or a placebo, over an eight-week dosing period.
Patient recruitment is on track to begin this month.
