When the TGA initially set the maximum dose for over-the-counter CBD at 60mg, most companies feared it was too low to prove efficacy. Avecho CEO Paul Gavin explains why the biotech firm was “probably the only company in Australia that was disappointed when it went up to 150mg” and outlines the next steps in the race for registration. Steve Jones reports.
Biotech firm Avecho is close to unveiling the next stage of its CBD drug registration pathway with scientists in the final stages of settling on an indication that will underpin its pivotal phase III clinical trials.
The decision, expected imminently, will mark another critical milestone in Avecho’s quest to register an S3, over-the-counter product with the Therapeutic Goods Administration (TGA).
The company is also expected to lodge a pre-submission package with the TGA within the next two months that will set out the work it has already done, and the clinical plan it intends to follow, in order to secure drug registration.
The developments emerged as Avecho prepares to carry out a phase I clinical trial to characterise the absorption profile of CBD in 16 healthy volunteers. The firm received ethics approval in April with the trial due to begin in Q3 2021.
Avecho chief executive Paul Gavin said work towards pharmaceutical registration was progressing, with the company now in the “final steps” of picking an indication for the phase III trial.
“We’re doing all the work to put plans in place for the phase III efficacy studies that we need to get it into TGA registration,” he said. “We’re running on all fronts in parallel just to make sure we’re not wasting any time and to get to the finish line as fast as possible.”
At the centre of Avecho’s registration goal is its vitamin e-based proprietary technology platform, TPM, which it says increases the absorption of CBD when compared to standard preparations. The company said its oral CBD formulation has already been shown to increase the bioavailability of CBD in animal models.