Melbourne-based biotechnology company Avecho’s patented TPM technology could boost absorption of CBD products and help the industry demonstrate efficacy at low doses, according to company CEO Dr Paul Galvin.
TPM technology uses phosphorated vitamin E in combination with oil-based products such as CBD to improve emulsification and absorption in the gut.
It is estimated that only 3-8% of oral cannabinoids consumed are absorbed into the bloodstream – the rest are broken down or excreted.
Avecho CEO, Biochemist Dr Paul Gavin said the company has seen a 40 times increase in CBD absorption in the animal trials it has just completed.
The TPM technology is now progressing to an observational study, as well as a Phase 1 PK study in humans. If successful, this will allow TPM to receive pharmaceutical product registration. The Phase I study will be used to support future product label and pharmaceutical product registration for the enhanced CBD product.
It follows trials in Denmark that showed proven increases in absorption.
Gavin said: “It’s not likely to be that high [CBD absorption] in humans, but even if we could increase absorption by two times, that would be a huge win. CBD dosing is really high so TPM could potentially improve results at lower doses.”
In its interim decision on the down-scheduling of CBD announced in September, the TGA limited the maximum dose of oral ingestibles to 60mg per day in a move which left many in the industry fearing they would be unable to prove efficacy at that level.
“If our formulation can increase absorption, that would mean patients could get good results from the proposed 60mg doses,” said Gavin.
Feedback from industry partners has been positive, with many companies saying that product differentiation in the CBD space is their biggest challenge.
“We’re open to discussions with other players in the space who want to licence our technology to create that point of difference,” added Gavin.
Avecho could also consider selling its own product line through SAS-B registration.
Beyond the bioavailability-boosting benefits of its TPM technology, Gavin said the vitamin E phosphates offer complementary benefits including antioxidant and anti-inflammatory impacts.
Gavin said he expects the observational trial to run well into 2021, with the Phase I study delivering high-level results by mid-next year.