Avecho Biotechnology Ltd (ASX:AVE, OTC:AVEFF, FRA:OEZ) has completed the treatment phase for the final patient required for the planned interim analysis of its pivotal Phase III insomnia trial.
The interim cohort includes 244 participants, who were randomised across 3 groups to receive nightly doses of either 150mg cannabidiol (CBD), 75mg CBD or placebo in Avecho’s TPM®-enhanced capsule.
Completion of treatment marks the final clinical milestone before the planned interim analysis, with results on track for late June 2026.
First efficacy readout in sight
The interim analysis is expected to provide the first indication of the product’s efficacy profile, help determine the final trial size and support Avecho’s ongoing licensing discussions.
The company will now lock and clean the clinical database ahead of statistical analysis. An independent blinded statistics team will conduct the analysis and provide results to Avecho’s independent Data Monitoring Board, which will review the outcomes and make recommendations under the study protocol.
Avecho CEO Dr Paul Gavin said completion of the treatment phase was a major milestone that brought the company closer to the first efficacy readout from the pivotal trial.
“Completion of the treatment phase for the interim analysis cohort is a major milestone for Avecho and brings us significantly closer to the first efficacy readout from our pivotal Phase III insomnia trial. With 244 participants now recruited and having completed treatment, the interim analysis remains on track for late June and is expected to provide important insight into the product’s efficacy profile and the pathway forward for the program.
“With Sandoz already established as our Australian commercial partner, a positive interim analysis outcome has the potential to materially de-risk the program and strengthen Avecho’s position in discussions relating to commercialisation opportunities outside Australia.”
Avecho’s Phase III trial is designed to support registration of its CBD TPM capsule with the Therapeutic Goods Administration for the treatment of insomnia.
The company has already licensed Australian commercial rights to Sandoz AG under a 2025 agreement that included a US$3 million upfront payment, up to US$16 million in milestones and tiered royalties of 14–19% on net sales.
Gavin said a positive interim outcome could materially de-risk the program and strengthen commercialisation discussions outside Australia.