Avecho Biotechnology Limited announced it has received ethics approval for its pivotal Phase III clinical trial testing its oral CBD softgel capsule for insomnia. The study will be a multicenter study conducted in up to 10 sites around Australia. The lead site will be Monash Medical Centre in Melbourne, Australia under the supervision of Principal Investigator, Associate Professor Darren Mansfield, Deputy Director of Monash Health.

The study will enrol 540 patients 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 have two primary endpoints: To investigate the effect of the administration of 75 mg and 150 mg per day CBD TPM® capsules versus placebo on reductions in insomnia severity after 8 weeks of treatment, as measured by the Insomnia Severity Index (ISI), and; To investigate the effect of the administration of 75 mg and 150 mg per day CBD TPM® capsules versus placebo on reductions in insomnia severity after 8 weeks of treatment, as measured by subjective sleep efficiency. Avecho has already established the single dose absorption profile from its softgel capsule, but blood will be collected across the 8 week study period 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 to conduct a powering and futility assessment. The powering calculation will be used to confirm the number of patients required to complete the study. The futility assessment will be used to determine whether there is any effect present in the study, or whether it should be terminated early.