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Avecho Biotechnology Limited (ASX:AVE)

ALERT: Price-sensitive ASX Announcement for AVE
Current share price for AVE : $0.020 0.01 (100%)+
Announcement
Release
18 Dec 2025 10:32AM
Price at Release
$0.010
Full Release
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Summary
Avecho Biotechnology Limited, under the ASX code AVE, has announced progress in the recruitment phase of its Phase III clinical trial involving oral CBD TPM®-enhanced capsules for the treatment of insomnia. With 190 participants already dosed out of the required 210 for the trial's interim analysis cohort, the company is nearing completion of this phase. Recruitment will continue into early 2026 due to stringent participant criteria. The primary goal is to evaluate the product's efficacy and safety, ultimately aiming for pharmaceutical registration with the Australian Therapeutic Goods Administration. The trial is significant in Australia due to recent regulatory changes allowing over-the-counter CBD sales. The interim analysis is expected to be completed by the first half of 2026.
Key Points
  • Recruitment for the 210-patient interim analysis cohort is nearly complete with 190 participants dosed.
  • Interim analysis timelines will be confirmed upon the completion of recruitment.
  • The trial investigates the use of oral CBD TPM®-enhanced capsules for insomnia treatment.
  • Avecho aims to submit for pharmaceutical registration with the TGA after the Phase III trial.
  • The trial is designed to comply with regulatory requirements from TGA, FDA, and EMA.
  • Participants are randomized into groups for an 8-week treatment with either CBD or placebo.
  • Australia's regulatory changes in 2020 allow for OTC CBD sales, presenting a market opportunity.
  • Avecho's CBD TPM® soft-gel capsule enhances CBD absorption, currently in Phase III development.
IMPORTANT NOTE: This information is autogenerated and has not been reviewed for accuracy or completeness. You should refer to the full announcement here for further information.