Positive interim analysis advances Avecho Phase III insomnia program

About this update from Avecho Biotechnology Limited

MELBOURNE, Australia, June 29, 2026 /PRNewswire/ -- Avecho Biotechnology Limited (ASX: AVE) ("Avecho" or "the Company") has announced it will continue with recruitment for its world-first Phase III insomnia program following a positive interim analysis evaluating its TPM®-enhanced cannabidiol (CBD) capsule. The interim analysis represents a major value-inflection point for the program, reducing clinical development risk and providing a defined pathway toward completion of the pivotal study. The independent Data Monitoring Board (DMB) has completed its review of the unblinded interim analysis data from the pivotal Phase III clinical trial. The DMB is comprised of independent experts in sleep medicine, clinical safety and biostatistics and is the only body with access to unblinded trial data. The DMB has unanimously recommended the trial continue to the full planned enrolment of 519 participants. The recommendation is highly encouraging as it confirms the study has satisfied the pre-specified criteria established in the trial protocol to progress beyond the interim analysis and continue recruitment of a second patient cohort. Avecho CEO Dr Paul Gavin said: "This is an important and major milestone for Avecho, and exactly the outcome we designed this trial to achieve. We have always said the trial's design - its two independent endpoints, stringent inclusion and exclusion criteria, and controls on the placebo effect - was its greatest strength in giving the product the best chance to show its effect, and the positive DMB recommendation vindicates that approach. "Although we remain blinded and the study is not complete, so final outcomes cannot be determined until then, we are more confident than ever that our CBD capsule works as a treatment for insomnia." The interim analysis was conducted on data from 244 participants randomised across three treatment groups receiving nightly doses of either 150mg CBD, 75mg CBD or placebo in a TPM®-enhanced capsule over an eight-week treatment period. Safety data reviewed at the interim analysis further supported the program, with no serious adverse events (SAEs) recorded across the 244 participants. Tolerability is central to the commercial rationale for the product. Avecho CEO Dr Paul Gavin added: "Our focus is now shifting toward commercialisation, and how this product is positioned against the medicines people currentl...

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