Avecho Biotechnology Limited announced interim results from comparative pharmacokinetic studies conducted in the UK, showing that Avecho's oral cannabidiol ("CBD") product under development has increased bioavailability compared to Epidiolex«, the only FDA approved CBD product. The current study characterized and compared the CBD absorption profile from single dose of (i) the Avecho TPM« CBD formulation, (ii) CBD dissolved in the simple oil vehicle (MCT), (iii) the commercial Epidiolex« formulation and (iv) a formulation with TPM« dissolved directly into the commercial Epidiolex« formulation (Epidiolex + TPM«). All test formulations were administered to fasted dogs via oral gavage and characterized over 24 hours.

The average area-under-the-curve ("AUC") of the CBD absorption profile and peak plasma concentration (Cmax) were calculated for each formulation. AUC represents the amount of drug absorbed after administration and is used to compare relative drug absorption between treatments. Both AUC and Cmax are standard measurements used to characterise drug absorption.

Study results: Avecho's clinical CBD TPM« formulation produced higher average AUC and Cmax than the CBD MCT control and the commercial Epidiolex« formulation. The Avecho CBD formulation increased average AUC by 4 and average Cmax 2.5 times when compared to Epidiolex«. The Epidiolex« + TPM« formulation increased average AUC by 4 times and average Cmax by 3 times when compared to Epidiolex«.

No symptoms of gastro-intestinal ("GI") irritation were observed for the clinical Avecho CBD formulation or the Epidiolex« + TPM« formulation, despite the four-times increase in average CBD absorption. The study is ongoing and will now assess the absorption of these formulations when accompanied by a meal; a factor known to increase the absorption of CBD. While the increased bioavailability produced by formulations containing TPM« is important, it was equally significant that the increase in absorption from TPM« formulations did not produce any observable GI issues.

Increasing the dose of CBD products, including Epidiolex«, can cause diarrhea and GI distress. This GI irritation can be prohibitive for indications requiring high doses of CBD, and industry has been looking for a way to increase the CBD dose without increasing the associated irritation. Dogs are an especially sensitive model for the assessment of GI irritation.

No GI irritation was observed for the Avecho formulation or the Epidiolex + TPM« in dogs, despite the four-fold increase in CBD absorption. TPM« formulations may therefore be appropriate in the future for indications that require very high doses of CBD. The increased absorption of the Avecho CBD formulation versus controls has now reproduced across two independent animal models; rodent and dog.

These 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.