Avecho Biotechnology (ASX: AVE) has received patent allowances from both the US Patent and Trademark Office and the European Patent Office for its cannabidiol (CBD) TPM soft-gel capsule.
Once the patents are formally granted, the allowances cover the company’s proprietary tocopheryl phosphate mixture–based formulation – which is in Phase III clinical development for insomnia – until at least 2040.
The coverage extends beyond CBD to include formulations using other cannabinoids, enabling future commercialisation opportunities outside the company’s core insomnia program.
Chief executive officer Paul Gavin said the allowances mark “an important milestone for Avecho,” and reinforce the company’s leadership in cannabinoid formulation technology as it progresses toward regulatory submissions.
Phase III Trial Progress
The CBD TPM capsule is currently being evaluated in a pivotal Phase III, multi-centre, randomised, double-blind, placebo-controlled clinical trial for the treatment of insomnia.
The study – the largest global clinical trial of cannabidiol for insomnia – was designed in consultation with international sleep and regulatory experts to meet requirements of the Therapeutic Goods Administration (TGA), US Food and Drug Administration, and European Medicines Agency.
Avecho expects a planned interim analysis of the first 210 patients in the first half of 2026, and believes positive results will support a regulatory submission to the TGA.
The company believes it has a potential first-mover advantage as no other Phase III CBD insomnia trials in Australia have succeeded to date.
Diverse TPM Applications
Derived from Vitamin E, the TPM drug-delivery system has been shown to improve solubility, stability, and absorption of active pharmaceutical ingredients across oral, dermal and transdermal applications.
Avecho said approval of the capsule in Australia could enable over-the-counter pharmacy sales under regulatory changes introduced in 2020 that allow low-dose CBD products to be supplied without prescription once registered.
Market forecasts indicate the over-the-counter CBD segment could exceed US$125 million per annum locally.
Avecho’s broader pipeline includes TPM-enhanced injectable, oral, and topical products for human health alongside its ongoing development of TPM applications in animal health.
The company noted that expanding patent protection across major markets strengthens its global commercial position as it advances the CBD TPM capsule toward registration.
