Avecho Biotechnology receives ethics approval for phase III insomnia clinical trial

Avecho Biotechnology Limited (ASX: $AVE) has received Ethics Approval for its pivotal Phase III clinical trial testing its oral CBD TPM-enhanced soft-gel capsule for insomnia. The trial is set to commence this month in Melbourne, Sydney, Central Coast, Brisbane, and Perth.

Executive Commentary on Phase III Clinical Trial Approval

We are very pleased to complete one of the final steps in our Phase III trial program prior to commencement, with the formal approval of changes that will allow for a more efficient study. In addition to this, we've continued preparations with our team of clinical trial providers, finalized the key manufacturing elements, and we have had constructive dialogue with the TGA. We expect that all of this sets a strong foundation for what will be the largest and most robust Phase III CBD study in Australia thus far. We are now excited to start.

Summary of Avecho Biotechnology's Phase III Clinical Trial Approval

Avecho Biotechnology Limited (ASX: $AVE) has successfully received Ethics Approval for its pivotal Phase III clinical trial testing its oral CBD TPM-enhanced soft-gel capsule for insomnia. The approval includes measures to streamline and enhance efficiency within the trial, reinforcing the planned study design and more efficiently deploying funds made available to the Company following its capital raise in 2023. The Phase III study will test its oral CBD TPM-enhanced softgel capsule for the treatment of insomnia, targeting enrolment of 519 patients across three treatment groups to compare nightly CBD doses of 75 and 150mg CBD with placebo over an eight-week dosing period. Recruitment for the Phase III trial is on schedule to commence this month, with potential participants encouraged to stay tuned to the Avecho website for instructions on how to register their interest to get involved. Avecho's ambitions include developing and commercializing innovative products using its proprietary Tocopheryl Phosphate Mixture (TPMR) drug delivery system, with a focus on enhancing the solubility and oral, dermal, and transdermal absorption of drugs and nutrients. The Company is also developing TPM® to enhance the feed efficiency and health of livestock.