Phase III CBD Clinical Trial Recruitment Update

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Stock Avecho Biotechnology Ltd (AVE.ASX)
Release Time 18 Dec 2025, 10:32 a.m.
Price Sensitive Yes
 Avecho Provides Phase III CBD Clinical Trial Recruitment Update
Key Points
  • Recruitment for 210-patient interim analysis cohort approaching completion
  • Total of 190 participants dosed with study medication
  • Interim analysis timelines to be confirmed upon completion of recruitment
Full Summary

Avecho Biotechnology Limited (ASX: AVE) has provided a progress update on the recruitment for its pivotal Phase III clinical trial investigating the use of its oral CBD TPM-enhanced capsule for the treatment of insomnia. The company continues to make steady progress toward the completion of patient recruitment for the planned interim analysis. As of the announcement date, 190 participants have been dosed with the study medication, representing the majority of the approximately 210 randomized participants required for the interim analysis cohort. Recruitment will continue into early 2026 to recruit the remaining participants. The pace of recruitment reflects the highly specific inclusion and exclusion criteria required for participation in this trial, which is designed to enroll a specific patient population most appropriate for assessing the product's efficacy and safety. Upon completion of recruitment, the company will focus on the final steps to conduct the interim analysis. Avecho expects to announce timelines for the interim analysis once recruitment is complete, with completion of the interim analysis targeted for the first half of 2026.