Avecho Biotechnology has completed recruitment for the interim analysis cohort of its Phase III insomnia trial evaluating an oral CBD capsule, a key step in its bid to register Australia’s first over-the-counter CBD product.
The firm confirmed it had enrolled approximately 210 participants, with results expected in June.
The data will provide the company with the first indication of the product’s efficacy and help determine the final sample size required to complete the study.
Avecho is seeking to generate evidence to support registration with the Therapeutic Goods Administration (TGA), which would allow the product to be sold as a schedule 3 medicine through pharmacies, without a prescription.
The firm struck a 10-year development and licensing agreement with pharmaceutical firm Sandoz in 2025 covering the Australian market.
Under the deal, Avecho received an upfront US$3 million (A$4.3m) payment and could receive up to US$16 million (A$22.9m) in development milestones ahead of commercial sales, alongside royalties ranging from 14% to 19% on net sales.
Chief executive Dr Paul Gavin described the recruitment milestone as a “significant inflection point” for the program.
“[It brings] us within sight of a long-anticipated result supporting the efficacy of our product,” he said. “With a commercial partnership with Sandoz already in place for Australia, the upcoming interim analysis represents a potentially transformative catalyst for Avecho.”
Gavin added that “a positive outcome would materially de-risk the program and increase its attractiveness to prospective partners around the world”.