• Independent Data Monitoring Board recommends continuing the Phase III trial at the planned enrollment size
• No serious adverse events identified in the interim analysis
• Positive interim results de-risk the CBD TPM insomnia product and strengthen Avecho's commercial position

Avecho Biotechnology Limited (ASX: AVE) has announced positive interim results from its pivotal Phase III clinical trial for its TPM-enhanced cannabidiol (CBD) capsule for insomnia. The independent Data Monitoring Board (DMB) has recommended continuing the trial at the originally planned enrollment of 519 participants. The interim analysis confirmed that the study met the pre-specified criteria, with no serious adverse events reported among the 244 participants assessed. This outcome de-risks the clinical development of the CBD TPM insomnia product, supporting Avecho's regulatory and commercial strategies. The positive results also strengthen Avecho's position for ongoing licensing discussions outside Australia. The company plans to accelerate recruitment for the second patient cohort using additional clinical sites.

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The positive interim results support Avecho's continued development of the CBD TPM insomnia product and enhance its commercial potential.