Avecho Biotechnology Limited (ASX: $AVE) commences pivotal phase III clinical trial for insomnia

Avecho Biotechnology Limited (ASX: $AVE) has initiated patient recruitment for its pivotal Phase III clinical trial testing its oral cannabidiol TPM©-enhanced soft-gel capsule for insomnia. The trial, the largest of its kind, aims to recruit 519 patients across multiple Australian sites and will compare nightly doses of Avecho's proprietary oral cannabidiol TPM©-enhanced soft-gel capsules at doses of 75 and 150mg cannabidiol with placebo over an 8-week dosing period.

Executive Commentary

Avecho CEO, Dr Paul Gavin, expressed, 'Avecho's pivotal Phase III clinical trial testing our oral CBD TPM- enhanced soft-gel capsule is the largest and most robust trial of its kind assessing cannabidiol's effect on insomnia, and will aim to prove, with meticulous trial design and regulatory compliance, a place for CBD in the treatment of insomnia. It presents an incredible commercial opportunity for Avecho, and we look forward to first working toward interim analysis results by the end of the calendar year. It's a huge feat to prepare for and fund a late-stage trial of this magnitude, and I would like to thank our entire team and valued investors for supporting us to reach this defining milestone for Avecho and Australia's innovation sector at large.'

Summary

Avecho Biotechnology Limited (ASX: $AVE) has commenced the pivotal Phase III clinical trial for its oral cannabidiol TPM©-enhanced soft-gel capsule for insomnia, aiming to recruit 519 patients across multiple Australian sites. The trial, designed to meet the requirements of key global regulatory agencies, seeks to prove the efficacy of its enhanced cannabidiol formulation to become the first company to commercialize a cannabidiol treatment for insomnia as a registered pharmaceutical medicine. With the global insomnia market estimated at more than $4 billion, the trial presents a significant commercial opportunity for Avecho. The company's CEO, Dr Paul Gavin, highlighted the trial's importance and expressed gratitude to the team and investors for their support. The Deputy Director of Monash Lung and Sleep, Associate Professor Darren Mansfield, emphasized the unmet treatment need for an over-the-counter, effective, fast-acting treatment for insomnia. The trial's recruitment portal is available for eligible participants, and Avecho is focused on achieving interim analysis results by the end of the calendar year.