Avecho Biotechnology (AVE) Study Update summary

Study progress and recruitment

• 131 patients have been dosed in the pivotal Phase III trial for CBD TPM-enhanced capsules targeting insomnia.

• Recruitment accelerated after activating three new clinical trial sites in Sydney and the Gold Coast.

• Target of 210 randomized patients for interim analysis expected to be reached in the second half of 2025.

• Interim analysis results anticipated in early 2026.

• Changes to inclusion/exclusion criteria and new sites have significantly improved recruitment rates.

Study design and objectives

• The trial is a multi-centre, randomized, double-blind, placebo-controlled Phase III study.

• Participants receive either 75mg or 150mg CBD or placebo nightly for eight weeks.

• Efficacy and safety are assessed using validated questionnaires and daily sleep diaries.

• The study is designed to meet TGA, FDA, and EMA regulatory requirements.

• Largest Australian Phase III trial of cannabidiol for insomnia, with sites in Melbourne, Perth, Sydney, and the Gold Coast.

Market and regulatory context

• Successful completion of the trial supports a TGA submission for over-the-counter registration of the product.

• No other Phase III CBD trials for insomnia have succeeded in Australia, offering a first-mover advantage.

• Australian over-the-counter CBD market projected to exceed US$125M annually.

• Insomnia affects up to 237 million globally, with significant economic impact in Australia.

• Regulatory changes in 2020 allow pharmacy sales of approved CBD products without prescription in Australia.