Avecho Phase III insomnia trial advances following positive interim analysis
Avecho has announced a positive outcome from the interim analysis of its pivotal Phase III insomnia trial evaluating its CBD TPM® capsule.
Following review of the unblinded interim data, the independent Data Monitoring Board unanimously recommended that the trial continue to its originally planned enrolment of 519 participants, having satisfied the pre-specified efficacy and safety criteria established in the trial protocol.
This is a major milestone for Avecho’s lead clinical program.
Importantly, the trial will continue at the originally planned sample size, rather than requiring an expanded number of participants. This is consistent with the treatment effect and data variability assumed in the study design and provides further confidence in the clinical pathway Avecho has built.
Safety was also a key criterion for the interim review, with no serious adverse events identified across the 244 participants assessed to date.
The study remains blinded and ongoing, and final outcomes cannot be determined until completion. However, this positive interim outcome materially de-risks the program and strengthens Avecho’s position as it advances the next stage of development.
With Sandoz already in place as Avecho’s Australian commercial partner, the Company is now well positioned to progress regulatory and commercial planning as it advances its CBD TPM® capsule toward potential registration and commercialisation.
Avecho CEO Dr Paul Gavin said:
“This is a major milestone for Avecho. For three years, our focus has been assessing whether this product works. From here, we are planning the business on the assumption that it does.
“That shifts our organisational priority to commercialisation, and in particular 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 licensing discussions. We remain blinded and the study is not complete, so final outcomes cannot be determined until then. But this data analysis has provided us with more confidence than ever that our CBD TPM® capsule has the potential to be an effective, differentiated new treatment for insomnia.”