Positive interim analysis advances Avecho Phase III insomnia program

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 currently rely on for sleep. Many existing prescription treatments carry well-documented limitations, including next-day impairment and the risk of overdose - concerns that cannabidiol's safety profile does not share.

"A treatment that can improve sleep without that safety burden has a clear place in the market and will be central to our ongoing licensing discussions."

About Avecho's Phase III Trial Program

The Company is currently conducting a pivotal (Phase III), multi-centre, randomised, double-blind, placebo-controlled clinical trial evaluating the efficacy and safety of CBD TPM soft-gel capsules in adults for use in the reduction of insomnia severity. 

The trial is the largest of its kind testing cannabidiol, taking place at multiple sites around Australia. Aided by advice from international sleep and regulatory experts, the trial has been designed to meet the requirements of the Australian Therapeutic Goods Administration ("TGA"), US Food and Drug Agency and the European Medicines Agency. 

Trial Participants will be randomly assigned to one of three groups to receive nightly doses of either 75mg or 150mg of CBD, or a placebo for eight weeks. Participants will use validated questionnaires and daily sleep diaries over the course of the study to record the duration and quality of their sleep. 

Further information about the study can be found at ClinicalTrials.gov (Study Identifier: NCT05840822).

Regulatory and Commercial Progress

In 2025, Avecho licensed Australian commercial rights to the CBD TPM capsule to Sandoz under an agreement that included a US$3 million upfront payment, potential development and commercial milestones of up to US$16 million and tiered royalties on future sales.^[1]

The positive interim analysis strengthens Avecho's commercial position and adds momentum to ongoing licensing discussions covering territories outside Australia.

The Company believes the interim outcome enhances the attractiveness of the program to potential commercial partners and strengthens the product's positioning against existing sleep medications. Accordingly, progressing additional regional licensing agreements will be a key strategic priority as Avecho seeks to fund continued development while maximising shareholder value.

The Company will also now look to engage with the FDA and other international regulatory agencies to determine the path forward for the product in specific geographies.

^[1] https://announcements.asx.com.au/asxpdf/20250303/pdf/06g5xlzjwc3h7z.pdf

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SOURCE Avecho Biotechnology Limited