Avecho Biotechnology has claimed its TPM CBD formulations have demonstrated superior bioavailability in dogs than one of the only approved cannabis medications, Epidyolex.
Interim results show TPM had four times higher absorption rates than Epidyolex using the area-under-the-curve (AUC) measurement, while peak plasma concentration (Cmax) was two-and-a-half times higher.
Both AUC and Cmax are standard measurements to characterise drug absorption.
All test formulations were administered to fasted dogs.
Of equal importance, according to Avecho, was that the TPM formulations did not produce any observable gastrointestinal irritation (GI) issues.
Increasing the dose of CBD products, including Epidyolex, can cause diarrhoea and GI distress, Avecho said, with dogs an “especially sensitive model for the assessment of GI irritation”.
“This GI irritation can be prohibitive for indications requiring high doses of CBD, and the industry has been looking for a way to increase the CBD dose without increasing the associated irritation,” the company said. “TPM formulations may therefore be appropriate in the future for indications that require very high doses of CBD.”
Avecho chief executive Paul Gavin said: “We have previously shown that our proprietary TPM formulations could increase the oral absorption of CBD in rats when compared to simple CBD oil formulations currently prescribed to patients in Australia.
“These formulations are now in clinical trials and will be entering Phase III clinical trials for an insomnia-related indication.”
He said the results validate the company’s choice of formulation for use in human trials seeking low-dose CBD approval, and “gives the product maximal chance of success in the upcoming Phase III”.
In addition to demonstrating greater bioavailability on its own, TPM also demonstrated enhanced bioavailability when added to Epidyolex.
Avecho described the findings as “especially noteworthy, as it demonstrates that TPM may be added to further products to increase their effectiveness”.
“A growing number of companies are now looking for ways to formulate and commercially differentiate their medicinal cannabis products,” the company said.
“Cannabinoid products with enhanced absorption, such as those identified in our recent animal studies, could offer significant therapeutic benefits to patients with commensurate commercial benefits to Avecho and its partners.
“In alignment with this, Avecho has recently begun formal business development outreach to the larger recreational cannabis space in North America, with this new data to be a feature of these discussions.”