Avecho Biotechnology (ASX:AVE) has announced that it has completed the treatment phase for the final patient needed for the planned interim analysis of its pivotal Phase 3 insomnia trial.
The cohort for the interim analysis now totals 244 participants who have completed treatment after being randomised to receive nightly doses of either 150 mg cannabidiol (CBD), 75 mg CBD or placebo in a TPM-enhanced capsule.
The company said completion of this treatment phase is the last clinical milestone before the locked clinical database is cleaned and an independent blinded statistics team performs the interim analysis, with results due in late June 2026.
The company said the interim analysis will provide the first indication of the product’s efficacy profile, help determine the final trial size and support ongoing licensing discussions. Avecho noted that the trial is designed to support registration of the CBD TPM capsule with the Therapeutic Goods Administration and to position the company to capitalise on the regulator's over the counter CBD registration pathway in Australia.
Avecho CEO Dr Paul Gavin said, "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 has previously licensed Australian commercial rights for the CBD TPM capsule to Sandoz in 2025 under an agreement that included an upfront payment of US$3 million, potential development and commercial milestone payments of up to US$16 million and tiered royalties of 14 to 19 per cent on net sales.