Avecho Biotechnology adds CBD soft gel capsule trials to clinical program

Pharmaceutical company Avecho Biotechnology (ASX: AVE) has announced an expansion of its clinical program to include oral trials using its cannabidiol (CBD) soft gel capsule.

The program is part of an ongoing collaboration with the Lambert Initiative at the University of Sydney, which has included a successful phase two clinical trial examining the use of a topic CBD TPM gel for the treatment of osteoarthritis of the fingers and hands.

Seven different clinical trials using Avecho’s TPM enhanced products are scheduled for 2023. These include a larger topical CBD trial currently being planned with the Lambert Initiative, as well as a further study to examine a topical cannabigerol (CBG) TPM product.

Finding new indications for Avecho’s CBD soft gel capsule

Avecho has developed an orally-administered CBD soft gel capsule, enhanced by its proprietary TPM technology to increase adsorption which is considered a major limitation of existing cannabinoid therapy.

While the company is focused on a pivotal phase three clinical trial testing the capsule in an insomnia indication, the Lambert Initiative will test the product on a series of novel candidate indications not previously associated with CBD therapy.

Lambert Initiative academic director Professor Iain McGregor said there is early evidence supporting the use of CBD in a “number of new clinical indications”.

Although he did not disclose the details of these, they are believed to represent attractive indications for future CBD products registered as over-the-counter (OTC) medicines with the Therapeutic Goods Administration (TGA).

“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,” he said.

First trial aims to dose patients by mid-year

The protocol for the first trial has already been submitted to ethics and will aim to dose patients in the middle of the year, Avecho reported. The second study will commence dosing in the third quarter.

Avecho chief executive officer Dr Paul Gavin said the Lambert Initiative’s decision to use the company’s CBD product in its own studies is testament to the clinical relevance of the work Avecho has conducted over the last three years on cannabinoid product development.

“While our company remains principally focused on the upcoming phase three 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,” he said.