Ann: AVE receives final ethics approval for Phase III CBD trial, page-2

ASX Announcement
7 March 2024
Avecho receives Ethics Approval for amendments to Phase III Insomnia
Clinical Trial
Highlights:
• Avecho’s Pivotal Phase III clinical trial testing its oral CBD TPM®-enhanced soft-gel capsule for
insomnia has gained final Ethics Approval.
• Patient recruitment for the Phase III is on track to commence this month for clinical trial sites located
in Melbourne, Sydney, Central Coast, Brisbane, and Perth.
Melbourne, Australia, 7 March 2024: Avecho Biotechnology Limited (ASX: AVE) (“Avecho” or the
“Company”, a biotechnology company focused on developing and commercialising innovative products using
its proprietary Tocopheryl Phosphate Mixture (“TPM®” drug delivery system, is pleased to announce it has
received Ethics Approval for its pivotal Phase III clinical trial testing its oral CBD TPM-enhanced soft-gel
capsule for insomnia, after the Company submitted amendments to the study in December 2023.
The approval includes measures to streamline and enhance efficiency within the trial, (i) reinforcing the
planned study design, further separating the methodology away from that employed in unsuccessful Phase
III trials for CBD in the treatment of insomnia in Australia to date - as well as (ii) more efficiently deploying
funds made available to the Company following its capital raise in 2023.
The changes also include the addition of new clinical trial sites, with a total of five to be used for the study,
located in Melbourne, Sydney, Central Coast, Brisbane, and Perth.
Avecho CEO, Dr Paul Gavin, said:
“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.”
Avecho’s 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