An independent board unanimously recommended continuing the trial of the TPM-enhanced cannabidiol capsule to full enrollment after reviewing safety and efficacy data from 244 participants.
Key takeaways:
- An independent data monitoring board recommended Avecho continue its phase III insomnia trial of a tocopheryl phosphate mixture-enhanced CBD capsule to a full enrollment of 519 participants.
- Interim safety data from 244 participants showed no serious adverse events across groups receiving 150mg CBD, 75mg CBD, or a placebo over eight weeks.
- Avecho plans to engage with the FDA and other international regulatory agencies to determine the regulatory pathway for the product in specific geographies outside of Australia.
Avecho Biotechnology Limited will continue recruitment for its phase III insomnia clinical trial evaluating a tocopheryl phosphate mixture (TPM)-enhanced cannabidiol (CBD) capsule following a positive interim analysis.
An independent data monitoring board, comprised of experts in sleep medicine, clinical safety, and biostatistics, completed a review of unblinded interim analysis data. The board unanimously recommended the trial continue to its full planned enrollment of 519 participants, confirming the study satisfied pre-specified criteria established in the trial protocol to progress and recruit a second patient cohort.
“This is an important and major milestone for Avecho, and exactly the outcome we designed this trial to achieve,” says Paul Gavin, PhD, CEO at Avecho, in a release. “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 [data monitoring board] recommendation vindicates that approach.”
The interim analysis evaluated data from 244 participants randomized across three treatment groups. Participants received nightly doses of either 150mg CBD, 75mg CBD, or a placebo in a TPM-enhanced capsule over an eight-week treatment period. Safety data reviewed during the interim analysis showed no serious adverse events recorded across the participants.
“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,” says Gavin in a release.
The ongoing pivotal, multi-center, randomized, double-blind, placebo-controlled clinical trial is taking place at multiple sites across Australia. Participants use validated questionnaires and daily sleep diaries to record the duration and quality of their sleep. The trial was designed with advice from international sleep and regulatory experts to meet the requirements of the Australian Therapeutic Goods Administration, US Food and Drug Administration, and the European Medicines Agency.
“Our focus is now shifting toward commercialisation, and how this product is positioned against the medicines people currently rely on for sleep,” says Gavin in a release. “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.”
Following the interim analysis, Avecho plans to engage with the FDA and other international regulatory agencies to determine the path forward for the product in specific geographies. Progressing additional regional licensing agreements is a strategic priority for the company, which previously licensed Australian commercial rights to the CBD TPM capsule to Sandoz in 2025.
