Avecho Biotechnology has restarted recruitment for the final stage of its pivotal Phase 3 trial of a cannabidiol capsule designed to treat insomnia, after an independent review found the study could continue without increasing its planned sample size.
The Melbourne-based company will recruit about 320 more participants for the second and final cohort, aiming for 519 people to complete the trial. It expects the remaining recruitment to take about 12 months once it activates additional clinical sites.
The decision follows an interim analysis involving 244 participants. An independent Data Monitoring Board, which alone has access to the unblinded trial data, unanimously recommended that the study proceed as originally designed. It did not call for additional participants, a result Avecho says indicates the study remains adequately powered and is tracking in line with its original assumptions.
Avecho itself remains blinded to treatment allocations and efficacy results. Final data will not be available until recruitment, treatment and subsequent analysis are complete.
The trial is testing Avecho’s TPM-enhanced cannabidiol soft-gel capsule in adults with insomnia. Participants are randomly assigned to receive either 75mg of CBD, 150mg of CBD or placebo each night for eight weeks. Researchers are using validated insomnia questionnaires and daily sleep diaries to measure changes in sleep quality and insomnia severity.
No serious adverse events were identified among the 244 participants assessed in the interim safety review across the three treatment groups.
Chief executive Paul Gavin described the interim analysis as the program’s most significant milestone and said the company now regarded the trial as materially de-risked.
Avecho will initially recruit through its existing clinical-site network before progressively opening further sites to accelerate enrolment. The company says it will apply the recruitment and site-management processes developed during the first stage of the trial as it works to complete the study.
The Phase 3 program is Avecho’s final clinical step before a potential application to the Therapeutic Goods Administration for registration of the CBD capsule as a treatment for insomnia. The company is pursuing a potentially important regulatory opportunity in Australia, where low-dose CBD products may be supplied over the counter through pharmacies if they receive the required approvals.
The trial is being conducted across multiple Australian sites and is designed as a randomised, double-blind, placebo-controlled study. Avecho says the program was developed with international sleep and regulatory advice and is intended to meet requirements relevant to the Australian regulator, the US Food and Drug Administration, and the European Medicines Agency.
