Avecho Biotechnology has identified a phase III clinical trial of its CBD soft-gel capsule as the “focus of 2022” as it continues efforts to register an over-the-counter schedule 3 product with the Therapeutic Goods Administration (TGA).
While acknowledging the “important” licensing progress its topical gel has made in recent months, the company said the focus was on demonstrating that its capsules are a remedy for insomnia-related indications.
Avecho has spent recent weeks revising the trial following feedback from the TGA.
The firm stressed that the trial design must be recognised by international regulatory bodies.
“While TGA registration is the initial focus, the company is adamant the study should be applicable to international regulatory agencies (FDA and EMA),” it said in a quarterly update to the ASX. “Consequently, design aspects related to the testing regime, the primary/secondary endpoints and patient inclusion/exclusion criteria become critical.”
Avecho said a team of local and international sleep experts have completed an initial study design, with the firm now “engaging the required clinical service providers to drive the study”.
“The phase III clinical trial will be the focus of 2022 and will kick off later this year,” the company said.
In addition to pursuing OTC product registration, the quarter saw Avecho announce positive results of a trial examining its topical gel in treating osteoarthritis of the hand and enter a licensing and supply agreement with Team SAAS for the use of its TMP formulation in recreational products in the US.
Meanwhile, Avecho reported operating expenditure of A$757,000 during the three months to March 31 with customer receipts of $360,000.
The company holds $2.44m in cash and this week received $1m under the government’s research and development tax incentive scheme.