• 131 patients dosed with study medication
• On track to complete recruitment of 210 patients for interim analysis in H2 2025
• Results of interim analysis expected in early 2026

Avecho Biotechnology Limited (ASX: AVE) is pleased to provide a progress update for its pivotal Phase III clinical trial investigating the use of its oral CBD TPM-enhanced capsule for the treatment of insomnia. The company has made changes to its inclusion and exclusion criteria and added new trial sites in Sydney and the Gold Coast, which have significantly accelerated patient recruitment. To date, 131 patients have received study medication, and Avecho expects to complete enrollment of the 210 patients required for the planned interim analysis in the second half of 2025. The results of the interim analysis are anticipated in early 2026. Avecho's CEO, Dr. Paul Gavin, stated that the changes made to the trial have had a measurable impact on recruitment, and the company now has a clear line of sight to the interim analysis, which is a key milestone. Avecho is focused on advancing the trial efficiently toward this important inflection point and will continue to keep the market updated on its progress.

Avecho expects to complete enrollment of the 210 patients required for the planned interim analysis in the second half of 2025, with the results of the interim analysis anticipated in early 2026. A successful Phase III trial is Avecho's final clinical step in support of a submission to the TGA for pharmaceutical registration of the CBD TPM soft-gel capsule for the management of insomnia.