Avecho Biotechnology has ramped up recruitment in its pivotal Phase III insomnia trial and is advancing plans for regulatory approval and commercialization of its TPM®-enhanced CBD capsule, aiming to be the first over-the-counter CBD insomnia treatment in Australia.
- Three new clinical sites activated in Sydney and Gold Coast
- 131 participants dosed, targeting 210 for interim analysis in early 2026
- Strategic collaboration with Sandoz AG for TGA registration and commercialization
- Cash balance of A$5.9 million with $1.66 million R&D tax incentive received
- Ongoing licensing discussions to expand beyond Australian market
Clinical Trial Momentum
Avecho Biotechnology Limited has reported significant progress in its Phase III clinical trial evaluating its proprietary TPM®-enhanced cannabidiol (CBD) soft-gel capsule for insomnia. The company has expanded the trial footprint by activating three new clinical sites, two in Sydney and one on the Gold Coast, accelerating participant recruitment. As of late July 2025, 131 participants have been dosed, moving steadily toward the target of 210 needed for a planned interim analysis expected in early 2026.
This trial is notable as the largest CBD insomnia study conducted in Australia, employing a rigorous randomized, double-blind, placebo-controlled design. It assesses two nightly doses of CBD (75 mg and 150 mg) over eight weeks, focusing on validated measures of sleep quality and duration. The interim readout will be a critical milestone, potentially paving the way for regulatory approval and commercial launch.
Regulatory and Commercial Strategy
Following a licensing agreement signed in March 2025, Avecho is collaborating closely with Sandoz AG, a global pharmaceutical company, to navigate the path toward Therapeutic Goods Administration (TGA) registration in Australia. The partnership aims to position Avecho’s TPM®-enhanced CBD capsule as the first over-the-counter (OTC) cannabidiol product approved for insomnia treatment in the country.
Australia’s regulatory reforms in 2020 allowing OTC sales of registered low-dose CBD products have opened a lucrative market opportunity, projected to exceed US$125 million annually. Avecho’s strategy to be first to market with a clinically validated, registered CBD pharmaceutical could establish a strong leadership position domestically and serve as a springboard for international expansion.
Financial Position and Licensing Expansion
As of 30 June 2025, Avecho held a cash balance of A$5.9 million, bolstered by a $1.66 million receipt under the Australian Government’s R&D Tax Incentive Scheme. These funds support ongoing clinical development, operational costs, and commercialization efforts. The company also repaid $1.04 million in R&D tax advances during the period.
Beyond Australia, Avecho’s CEO Dr Paul Gavin has actively pursued licensing opportunities, attending the BIO International Convention in the United States and engaging with potential partners across Europe. While no new agreements have been finalized, these efforts signal a clear intent to broaden the company’s commercial footprint globally.
Looking Ahead
The next six months will be pivotal for Avecho as it aims to complete enrolment for the interim analysis cohort and deliver initial Phase III results. Success here could validate the product’s efficacy and safety profile, underpinning regulatory submissions and commercial launch plans. Meanwhile, ongoing licensing discussions and strategic partnerships will be key to scaling the product’s reach beyond Australia.
Bottom Line?
Avecho’s accelerated trial and strategic partnerships set the stage for a potential breakthrough in OTC CBD insomnia treatment, but upcoming interim data will be the true test.
Questions in the middle?
- Will the interim Phase III results meet efficacy and safety expectations to support TGA approval?
- How quickly can Avecho and Sandoz commercialize the product post-approval in Australia?
- What progress will Avecho make in securing international licensing deals beyond Australia?