Avecho Biotechnology has targeted insomnia as the indication that will underpin pivotal phase III clinical trials and its quest to register an S3, over-the-counter product with the Therapeutic Goods Administration (TGA).

The biotech firm is proceeding to a pre-submission meeting with the TGA to present plans for the development and registration of its pharmaceutical CBD soft-gel product with its first target being for an insomnia-related indication.

The meeting will examine the proposed indication and appropriateness of Avecho’s planned clinical program to support product registration as a Schedule 3, pharmacist-only medicine. It will address the design aspects of the phase III study, together with the available safety information related to the cannabidiol and the soft-gel product.

Avecho’s product contains 75 mg per capsule, bringing it within the maximum 150g daily dose allowed by the TGA when it announced its decision to down schedule CBD late last year. It also contains TPM, which the company says increases the oral bioavailability of CBD.

Avecho has engaged Cannvalate’s Medicinal Cannabis Research Collaboration for the TGA pre-submission meeting.

Avecho CEO Dr Paul Gavin

CEO Dr Paul Gavin said: “We are committed to working closely and constructively with the TGA and other key regulators as we develop our clinical trial program and products, to ensure our company is primed to register our CBD soft-gel product in key markets.

“We have engaged the Cannvalate team to run the TGA pre-submission meeting due to their extensive experience in the Australian medicinal cannabis space with an emphasis on TGA interactions.”

While Avecho’s CBD soft-gel has the potential to treat a number of indications, the company has determined that insomnia should be the first cab off the rank.

Clinical trial data has demonstrated that CBD can increase sleep duration when compared against a placebo, in addition to reducing the time it takes to fall asleep. Some of these results were obtained using CBD doses above 150 mg, potentially biasing success in this indication towards products with increased bioavailability.

Gavin added: “We believe the choice of initial indication is crucial in determining who will be both clinically and commercially successful. The available S3 indications are typically subjective in nature and rely on self-reported patient questionnaires describing how they are feeling.

“Studies of this kind are more susceptible to placebo effects, which can increase the difficulty of seeing a beneficial medicinal effect.

“In addition to being a commercially attractive endpoint, our research indicated that the insomnia-related studies were less susceptible to placebo effect than some of the other candidate indications that were considered.”