Posted: 4 April 2023
Avecho Biotechnology Limited has today announced that it is undertaking a capital raise seeking approximately $11 million. Proceeds from the raise will be used to fund a pivotal Phase 3 clinical trial designed to test the Company’s proprietary CBD soft–gel capsule for the treatment of insomnia.
Avecho has developed the TPM® enhanced CBD soft–gel capsule with increased absorption over the last three years, proceeding through formulation development and optimisation, chemistry manufacturing and controls, and a Phase I clinical trial characterising the drug absorption from the product in humans.
The Company will now commence a pivotal randomized, placebo–controlled Phase 3 clinical trial, designed with leading clinical sleep researchers in Australia and internationally. The Study will be a rigorous investigation of the effectiveness of our proprietary CBD soft–gel capsule in the treatment of insomnia, targeting 540 patients across three treatment groups to compare nightly CBD doses of 75 and 150 mg CBD with placebo over an 8–week dosing period.
The Study is the last major piece of data required to support a future TGA submission. The TGA has not previously assessed CBD in a submission package for pharmaceutical approval –similarly, no regulatory agency in the world has approved CBD for an insomnia indication. Consequently, the planned study has been designed to maximise the chance of a successful Phase III trial, minimise potential reasons for the TGA to reject our future submission, and augment the chance of negotiating significant commercial deals with leading international pharmaceutical companies.
The entitlement offer announced today will allow the Company to drive the Phase 3 trial toward completion, which will be a significant inflection point for the Company.
