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Avecho Biotechnology (ASX: $AVE) prepares for pivotal Phase III trial targeting insomnia

Avecho Biotechnology's Quarterly Activities Report and Appendix 4C


Avecho Biotechnology Limited (ASX: $AVE) has released its Quarterly Activities Report and Appendix 4C for the quarter ended 31 December 2023. The Company's focus during the quarter was on preparations for the pivotal Phase III trial of its proprietary CBD soft gel capsule targeting insomnia, scheduled to commence late Q1 2024.

Executive Commentary on Phase III Trial and Market Opportunities


The Phase III trial for Avecho's proprietary CBD soft gel capsule has been carefully planned, involving three treatment groups and a randomized, placebo-controlled setup. The study will be conducted across five major cities in Australia, with 519 participants, demonstrating Avecho's commitment to demonstrating the effectiveness of CBD in treating insomnia. The interim analysis, scheduled for late calendar 2024, represents a critical inflection point and will evaluate sleep improvements in the three different groups without revealing group identities to the statisticians. The Company's strategic focus on insomnia leverages the prevalent condition to explore a potentially lucrative market segment, especially considering Australia's unique regulatory environment that allows OTC registration of pharmaceutical CBD products.

Summary of Avecho Biotechnology's Quarterly Activities and Outlook


Avecho Biotechnology's Quarterly Activities Report highlights the Company's strategic preparations for the pivotal Phase III trial of its proprietary CBD soft gel capsule targeting insomnia. The study's careful planning, large-scale approach, and unique interim analysis demonstrate Avecho's commitment to demonstrating the effectiveness of CBD in treating insomnia. Furthermore, the Company's strategic focus on insomnia leverages the prevalent condition to explore a potentially lucrative market segment, especially considering Australia's unique regulatory environment that allows OTC registration of pharmaceutical CBD products. The market dynamics and the regulatory landscape in Australia create a large opportunity for Avecho in the pharmaceutical CBD sector. The Company's ambitions to address a major health concern and capitalize on the growing demand for alternative, effective sleep aids position it for potential success in this emerging market.

Sourcehttps://announcements.asx.com.au/asxpdf/20240131/pdf/05zx3y7jby14hc.pdf

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