131 Patients Dosed as Avecho Targets 210 for CBD Insomnia Trial Interim Readout

Clinical Trial Momentum Builds

Avecho Biotechnology Limited (ASX – AVE) has provided a significant update on its pivotal Phase III clinical trial investigating a proprietary cannabidiol (CBD) capsule enhanced with Tocopheryl Phosphate Mixture (TPM) for treating insomnia. The company has now dosed 131 patients, moving steadily toward its target of 210 patients required for an interim analysis expected in the second half of 2025.

This progress follows the activation of three new clinical trial sites in Sydney and the Gold Coast, complementing existing sites in Melbourne and Perth. These additions, alongside revised inclusion criteria implemented late last year, have notably accelerated patient recruitment, a critical factor in maintaining the trial’s timeline.

Strategic Partnership and Market Potential

In March 2025, Avecho entered into a licensing agreement with Sandoz AG, granting Sandoz the Australian commercial rights to the CBD TPM capsule. This partnership has not only facilitated the expansion of trial sites but also positions Avecho to capitalize on evolving regulatory landscapes. Notably, regulatory changes in Australia now permit over-the-counter sales of approved CBD products, offering a lucrative pathway to market if the trial proves successful.

Insomnia affects an estimated 10-30% of the global population, with chronic cases impacting up to 15%. The global sleep aids market is projected to reach nearly US$1 trillion by 2032, underscoring the substantial commercial opportunity Avecho targets. In Australia alone, insomnia-related costs to the economy are estimated at A$19.1 billion, highlighting the societal need for effective treatments.

Trial Design and Regulatory Ambitions

The Phase III trial is a randomized, double-blind, placebo-controlled study designed with input from international sleep and regulatory experts to meet the stringent requirements of the Australian Therapeutic Goods Administration (TGA), the US Food and Drug Administration, and the European Medicines Agency. Participants receive nightly doses of either 75mg or 150mg of the CBD TPM capsule or placebo over eight weeks, with sleep quality and duration monitored through validated questionnaires and diaries.

A successful trial outcome would support Avecho’s submission for pharmaceutical registration, potentially making it the first company to bring a Phase III CBD insomnia treatment to market in Australia. This milestone could open doors to both prescription and over-the-counter sales, a significant commercial advantage given the growing consumer demand for sleep aids.

Looking Ahead

CEO Dr Paul Gavin expressed confidence in the trial’s trajectory, emphasizing the impact of recent strategic adjustments on recruitment rates and the clear path toward the interim analysis. The company plans to keep the market informed as it approaches this key inflection point, with interim results anticipated in early 2026.

For individuals interested in participating, Avecho continues to encourage registration at clinical trial sites across Melbourne, Sydney, Gold Coast, and Perth, reflecting the company’s commitment to robust and inclusive patient recruitment.