Ethics Approval for amendments to Phase III Clinical Trial
Avecho has today announced that 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 improve trial efficiency, and includes 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.”