Avecho Biotechnology (ASX: AVE) has received $1.66 million under the Australian Government’s Research and Development (R&D) Tax Incentive Scheme for the year ended December 31, 2024. These funds acknowledge Avecho’s commitment to developing differentiated cannabinoid formulations, particularly for pharmaceutical registration. A significant portion, $1.04 million, will be used to repay advances from Endpoint Capital related to prior R&D tax credits. The remaining funds will support the ongoing Phase III clinical trial for Avecho’s CBD TPM soft-gel capsule aimed at treating insomnia, as well as general company operations and the advancement of its commercialization strategy to bring innovative medicines to patients worldwide.
The Phase III trial, the largest of its kind for cannabidiol, is being conducted across multiple sites in Australia. It evaluates the efficacy and safety of CBD TPM soft-gel capsules in adults to reduce insomnia severity. The trial is designed to meet requirements of the Australian Therapeutic Goods Administration (TGA), US Food and Drug Agency, and the European Medicines Agency. Participants will receive nightly doses of either 75mg or 150mg of CBD, or a placebo, over eight weeks.
A successful Phase III trial would support Avecho’s submission to the TGA for pharmaceutical registration of its CBD TPM soft-gel capsule for insomnia management. Regulatory changes in Australia now allow over-the-counter sales of CBD products directly from pharmacies, provided appropriate approvals are obtained. Avecho aims to be the first to market in this area, with projections estimating the Australian over-the-counter CBD market could grow to over US$125 million per annum. The company’s TPM technology is also being applied to enhance feed efficiency and livestock health.
