Avecho’s CBD Soft-Gel Patents Allowed, Protection Extended to 2040

Patent Milestone Strengthens Global IP Position

Avecho Biotechnology Limited (ASX – AVE) has achieved a significant intellectual property breakthrough with the allowance of its patent applications by both the United States Patent and Trademark Office and the European Patent Office. These patents cover Avecho’s proprietary cannabidiol (CBD) soft-gel capsule formulation enhanced with Tocopheryl Phosphate Mixture (TPM), a Vitamin E derivative designed to improve CBD absorption.

The granted allowances mark a crucial step in protecting Avecho’s innovative oral cannabinoid delivery technology in two of the world’s largest pharmaceutical markets. The formal patent grants are expected by the end of the 2026 financial year, securing exclusivity for the formulation until at least 2040. This extended protection not only covers CBD but also formulations incorporating other cannabinoids, positioning Avecho for broader commercial opportunities beyond its current focus.

Advancing the Largest Global CBD Insomnia Trial

Parallel to its IP progress, Avecho is advancing a pivotal Phase III clinical trial evaluating the efficacy and safety of its CBD TPM soft-gel capsule for treating insomnia. This multi-centre, randomized, double-blind, placebo-controlled study is the largest global trial of cannabidiol for insomnia, designed with input from international sleep and regulatory experts to satisfy the stringent requirements of regulators including Australia’s Therapeutic Goods Administration (TGA), the US Food and Drug Administration (FDA), and the European Medicines Agency (EMA).

The trial involves administering nightly doses of either 75mg or 150mg CBD or placebo over eight weeks, with participants tracking sleep quality and duration. An interim analysis of approximately 210 patients is expected in the first half of 2026, a key catalyst that could pave the way for regulatory submissions.

Commercial Implications and Market Opportunity

A successful Phase III outcome would support Avecho’s planned submission to the TGA for pharmaceutical registration of its CBD soft-gel capsule for insomnia management. Notably, regulatory reforms in Australia since 2020 allow approved low-dose CBD products to be sold over the counter through pharmacies, potentially enabling Avecho to capture a first-mover advantage in a market forecast to exceed US$125 million annually.

CEO Dr Paul Gavin highlighted the significance of the patent allowances and clinical progress, emphasizing how these developments underpin Avecho’s leadership in cannabinoid formulation technology and strengthen its foundation for future commercial discussions.

Looking Ahead

As Avecho awaits the formal patent grants and interim clinical data, the company stands at a pivotal juncture. The convergence of robust intellectual property protection and clinical validation could unlock substantial value in the burgeoning cannabinoid pharmaceutical sector, particularly in insomnia treatment.