Avecho Biotechnology Limited (ASX:AVE) has confirmed the expansion of its ongoing collaboration with leading Australian research group for cannabinoid therapeutics, the Lambert Initiative at the University of Sydney.
The expansion will include a series of clinical trials examining new clinical indications for cannabidiol (CBD) using Avecho’s CBD soft-gel capsule.
Avecho has previously collaborated with the Lambert Initiative on a successful Phase II clinical trial examining the use of a topical CBD TPM gel for the treatment of osteoarthritis of the fingers and hands.
Results from this study were presented by Lambert Initiative researchers at the International Cannabinoid Research Society Symposium on the Cannabinoids in June 2022. A larger topical CBD trial is currently being planned with the Lambert Initiative for 2023, as is a further study that will examine a topical cannabigerol (CBG) TPM product.
Avecho has developed a proprietary oral CBD soft-gel capsule, enhanced by its proprietary TPM technology to increase absorption, a major limitation of existing cannabinoid therapy. While Avecho focuses its efforts on its pivotal Phase III clinical trial testing the CBD soft-gel capsule in an insomnia indication, the Lambert Initiative trials will test the product on a series of novel candidate indications not previously associated with CBD therapy. These candidate indications have emerged from pre-clinical and early-stage clinical studies conducted by Lambert Initiative researchers and their colleagues, and represent attractive indications for future CBD products registered as over-the-counter (OTC) medicines with the Therapeutic Goods Administration (TGA).
We have early evidence supporting the use of CBD in a number of new clinical indications and intend to examine these further in human clinical trials,” Professor Iain McGregor, Academic Director of the Lambert Initiative, said.
“We have been impressed by both the products, and the quality of the science, emerging from Avecho. Consequently, we are delighted to continue our productive collaboration with the company to use their oral CBD product for our forthcoming clinical trials examining novel indications.”
The protocol for the first trial has already been submitted to ethics and will aim to dose patients in the middle of the year. The second study will commence dosing Q3 2023.
“While our company remains principally focused on the upcoming Phase III trial of our oral CBD soft-gel product, it has always been our intention to allow others to examine further clinical applications of our formulations in other indications of value and interest,” Avecho CEO, Dr Paul Gavin, said.
“The Lambert Initiative are Australia’s foremost experts in cannabinoid research, and we have learnt much about the clinical potential of cannabinoids through our interactions. Their decision to use Avecho’s CBD product in their own studies is testament to the clinical relevance of the work we’ve conducted over the last three years on product development in the cannabinoid space.”
With the addition of the further Lambert Initiative studies, Avecho’s products will be used in seven clinical trials during 2023; the company’s pivotal Phase III insomnia trial, the Perland osteoarthritis study and the two new Lambert Initiative trials will use the oral CBD soft-gel capsule; Perrigo’s pain study will use topical ibuprofen; and both topical CBD and topical CBG will be examined in osteoarthritis of the hand in collaboration with the Lambert Initiative.