Biotech play Avecho (ASX:AVE) has made further progress into the cannabis industry, announcing today that it has received ethics approval to conduct a Phase I clinical trial to characterise the absorption profile of cannabidiol (CBD) in healthy humans.

Specifically, the study will measure the safety and absorption profile of the CBD formulation in its proprietary, vitamin E-based Targeted Penetration Matrix (TPM) technology, as it eyes TGA certification and labelling.

According to the company, TPM is the world’s first drug delivery platform combining a proprietary combination of two different forms of tocopheryl phosphate, an enhanced form of Vitamin E. Results have shown that reformulating with TPM increases drug solubility and oral bioavailablity in animal models- when compared to standard CBD preparations.

Proving that TPM can increase the absorption of cannabinoids will support the development of differentiated cannabinoid products on the market, and potentially lower cost to consumers.

Avecho seeks TGA cannabis approval

The study is to take place at CMAX in Adelaide with 16 healty volunteers. Established in 1993, CMAX is one of Australia’s largest and most experienced clinical trial centres.

The study will compare the absorption of CBD after consumption of soft-gel capsules at two different doses; 75mg and 150mg. These specific doses were chosen to align with TGA’s directions on CBD, which specified that future over-the-counter CBD products must be limited to a maximum daily dose of 150mg.

The 75mg CBD dose per soft-gel capsule meanwhile, will support twice daily dosing for cases benefiting from prolonged drug delivery, such as anxiety or insomnia. The gel used for the clinical trial is currently being produced by Catalent, a US global player in advanced drugs manufacturing.

Additionally, Avecho is already participating in the CA Clinics Observational Study (CACOS), Australia’s largest running observational study of medicinal cannabis products in patients, to learn how this product will perform on a range of cases that currently utilise medicinal cannabis therapy.

Timing for dosing the Phase I trial will depend on many factors, but is anticipated to be conducted in early Q3. The company is already planning bigger programs beyond the Phase I, including further pivotal trials and safety studies as it looks to submit a dossier to the TGA.

The TGA has begun accepting applications to include products containing up to 150mg of CBD on the Australian Register of Therapeutic Goods as schedule 3 medicine, meaning they could be dispensed by pharmacists without a prescription.

The race is on

The race is on for Australian pharmaceuticals to produce Australia’s first approved cannabidiol drug, and Avecho is hoping to become the first to do so.

“Medical cannabis is a new space for us,” Avecho chief executive Dr Paul Gavin told Stockhead. “We’re pure biotech… we’re a bit terrified of the space.”

Avecho’s last financial report, meanwhile, says that the company’s net loss increased by 410 per cent to $2.63 million for the full year ending 31 December.

Its share price rose by almost 10 per cent following today’s announcement, and has risen by 100 per cent over the last 12 months.


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