160 Patients Dosed as Avecho Raises $2.5M to Accelerate CBD Insomnia Capsule Launch

Steady Progress in Pivotal Phase III Trial

Avecho Biotechnology Limited (ASX, AVE) has reported continued recruitment progress in its Phase III clinical trial evaluating a cannabidiol (CBD) soft-gel capsule designed to treat insomnia. As of the end of September 2025, 160 patients have been dosed with the study medication, marking a significant milestone in what is the largest trial of its kind in Australia.

While recruitment experienced a moderate slowdown during the quarter due to an uptick in seasonal illnesses affecting trial sites, activity has since returned to normal levels. The company remains focused on completing recruitment for the interim analysis cohort, expected in the first half of 2026, which will provide critical data on the efficacy and safety of the CBD TPM formulation.

Strategic Collaboration and Trial Enhancements

Avecho’s partnership with global pharmaceutical giant Sandoz AG continues to be a cornerstone of the trial’s advancement. Together, they have refined the statistical analysis plan to enhance the sensitivity and robustness of the primary outcome measures, bolstering the scientific credibility and regulatory readiness of the study.

The trial itself is a rigorous, multicentre, double-blind, placebo-controlled study assessing two nightly doses of CBD (75 mg and 150 mg) against placebo over eight weeks. Participants track both sleep duration and quality using validated tools, aiming to provide comprehensive evidence to support regulatory approval.

Capital Raise Fuels Manufacturing and Regulatory Push

Post-quarter, Avecho successfully completed a $2.5 million capital raise, backed by institutional and sophisticated investors. This infusion of funds is earmarked to accelerate manufacturing scale-up, technology transfer activities with contract manufacturer Procap, and regulatory preparations ahead of a planned submission to the Australian Therapeutic Goods Administration (TGA).

The company is validating scaled manufacturing processes and producing registration batches, positioning itself to be the first to market an over-the-counter CBD insomnia treatment in Australia. Regulatory changes in 2020 have opened the door for such products to be sold directly from pharmacies without prescriptions, provided they meet approval standards.

Expanding Horizons Beyond Australia

Beyond domestic ambitions, Avecho is leveraging its licensing agreement with Sandoz AG to attract interest from pharmaceutical partners internationally. The company is actively pursuing licensing opportunities in other territories where regulatory frameworks for cannabinoid-based sleep therapies are evolving rapidly, potentially broadening its commercial footprint.

With a cash balance of $4.6 million at quarter-end and a clear operational focus on trial completion and regulatory submission, Avecho is navigating the critical final stages before potential market entry. The coming months will be pivotal as recruitment concludes and interim data readouts approach.