Australian-based Avecho Biotechnology (ASX: AVE) has signed a term sheet with US cannabinoid actives specialist Purisys LLC for the supply of synthetic, pharmaceutical-grade cannabidiol and dronabinol.
Avecho plans to combine the cannabinoids with its tocopheryl phosphate mixture (TPM) technology in the research and development of oral cannabinoid products for specific clinical indications and formal regulatory approval.
TPM is believed to be the world’s first drug delivery platform to feature a proprietary combination of two different forms of tocopheryl phosphate, which is an enhanced form of vitamin E.
Unlike normal vitamin E, TPM self-assembles into small particles – each measuring less than a 10th the thickness of a human hair – which are able to trap drugs or other molecules inside, thereby increasing their solubility and subsequent absorption.
TPM is believed to enhance vitamin E activity across a range of non-antioxidant roles and offers distinct commercial advantages to a range of dosage forms, including injectable, oral and topical or transdermal products.
Avecho has also agreed to purchase its future supply requirements from Purisys upon the commercialisation of its new cannabinoid products.
The synthetic cannabidiol produced by Purisys is distinguished by its ultra-high purity, commercial scale and low tetrahydrocannabinol (THC) concentration.
Avecho chief scientific officer Dr Paul Gavin said the decision to develop TPM-enhanced cannabinoid products follows experiments conducted at Purisys labs which have demonstrated the technology’s ability to increase the solubility of cannabinoids.
“The limited aqueous solubility of cannabinoids leads to poor oral bioavailability, high variability in absorption, and difficulty in developing aqueous dosage forms,” he said.
“TPM has been shown to reproducibly increase the bioavailability and duration of absorption of orally-ingested lipids, as well as increasing their solubility in aqueous mediums.”
The solubility profile of cannabinoids has been considered ideal for use in combination with TPM.
“It is anticipated that the inclusion of TPM will overcome many of the limitations of cannabinoid dosing which result from poor solubility and allow [us] to offer positively differentiated products with patent protection,” Dr Gavin said.
Medicinal and consumer cannabinoids represent approximately 40% of the global cannabis market and their value is expected to grow from around $8 billion in 2019 to more than $25 billion in 2025.
Avecho executive chairman Dr Greg Collier said both markets are the focus of industry interest and investment, and there is an associated growing interest from cannabinoid manufacturers and suppliers seeking differentiated products.
“At present, the cannabis extracts entering these spaces are very similar [and] we believe the addition of TPM will provide a commercially-advantageous differentiation,” he said.
“This agreement with Purisys provides the opportunity to combine our respective expertise in a way that can rapidly bring truly differentiated products to this exciting and growing market.”
Avecho aims to extract value from its TPM technology by developing products to a stage where the company can demonstrate technical differentiation and become attractive to potential partners.
While the company has a number of products at different stages of active development, it has also identified formulation and drug delivery problems in the emerging cannabis space.
“We intend to overcome these issues using the TPM delivery system, creating a differentiated, high-quality, pharmaceutical-grade product with a formal clinical indication,” Dr Collier said.
“We have recently announced the launch of this program to the market which has led to discussions with some of the larger manufacturing partners in the cannabinoid space.”
It is hoped the program will lead to additional licencing opportunities for the use of TPM in third-party medicinal cannabis products within Australia and North America.