Avecho Accelerates Phase III CBD Trial with New Sites and Manufacturing Milestone

Clinical Trial Progress and Recruitment Challenges

Avecho Biotechnology Limited (ASX: AVE) has reported steady progress in its Phase III clinical trial for its proprietary TPM®-enhanced CBD capsule aimed at treating insomnia. As of December 2024, approximately 70 patients have been dosed, marking a significant step forward in this pivotal study. However, recruitment during 2024 was slower than initially anticipated, primarily due to stringent inclusion and exclusion criteria designed to optimise the trial's success.

Recognising these challenges, Avecho submitted and received approval for amendments to the trial protocol in December 2024. These changes broaden the eligibility criteria and add two new recruitment sites on the Gold Coast and in Sydney, expected to become operational in early 2025. The company also indicated plans to potentially add further sites to accelerate enrolment, aiming to meet the interim analysis milestone scheduled for later this year.

Strategic Positioning and Industry Milestone Potential

Dr. Paul Gavin, Avecho's CEO, highlighted the strategic importance of the upcoming interim analysis, positioning the company to potentially become the first to report positive Phase III results for a CBD product targeting insomnia. This milestone is expected to catalyse further partnership discussions and licensing opportunities both domestically and internationally, underpinning Avecho's growth ambitions in the pharmaceutical cannabinoid space.

Manufacturing Achievements and Partner Collaboration

Alongside clinical development, Avecho has maintained strong operational momentum in manufacturing. The company completed a major production campaign for its U.S. partner Ashland LLC, delivering a total of 11 tonnes of Vital-ET® in 2024, with an additional 5.4 tonnes produced in January 2025. This robust manufacturing output supports Ashland's global personal care market supply and underscores Avecho's capability to scale production effectively.

Financial Overview and Funding Outlook

Financially, Avecho invested approximately A$1.2 million in research and development during the quarter, alongside corporate and employment costs of around A$248,000. The company received an R&D loan of A$301,000 from Endpoints Capital, contributing to a cash balance of A$2.374 million at quarter-end. While the current cash runway is estimated at 1.55 quarters, Avecho is actively engaged in licensing negotiations expected to provide additional capital to sustain the Phase III trial. The company also benefits from an R&D tax reimbursement mechanism to support its funding needs.

Looking Ahead

Avecho's focus in 2025 will be on accelerating patient recruitment, executing the interim analysis, and advancing licensing discussions. Success in these areas could significantly enhance the company's market positioning and unlock new revenue streams. Investors and industry watchers will be keenly observing the trial's progress and the outcomes of partnership negotiations as key indicators of Avecho's trajectory in the competitive cannabinoid pharmaceutical landscape.