Synthetic cannabidiol secured for acne program

Medical dermatology company Botanix Pharmaceuticals (ASX:BOT) has secured a supply of synthetic cannabidiol, manufactured at commercial scale by its US-based partner, to be used in the development of a treatment for skin diseases.

Unlike cannabidiol sourced from natural extracts, pharmaceutical-grade synthetic cannabidiol is of high purity and does not vary in strength or composition due to growing conditions, genetics of the source plant or extraction and purification processes. This means the company will not be required to comply with the extensive testing and controls in the US FDA’s ‘Guidance for Botanical Drug Products’ that applies to natural cannabidiol extract-based products.

“This is an important milestone in the development of an acne treatment that can be FDA approved and supplied commercially,” said Botanix Executive Director Matt Callahan. “Our use of synthetic cannabidiol substantially increases the likelihood that Botanix products can satisfy the stringent FDA requirements for purity and consistency and avoids the risks associated with natural extract-based products.”

The commercially synthesised cannabidiol will be used in Botanix’s lead development program for the treatment of acne, BTX1503. The company plans to advance the first of its products for the treatment of acne into clinical trials in humans in Australia in early 2017 and is exploring opportunities to leverage its skin delivery technology to rapidly advance other products into the clinic.

“Just like the earliest forms of aspirin were extracted from the bark of the willow tree, today we wouldn’t think of using a natural extract when we can chemically synthesise pure aspirin at industrial scale for pain relief,” noted Callahan. “The use of cannabidiol for pharmaceutical treatments needs to go the same way and Botanix are leading that development with our skin disease products.”

Botanix Pharmaceuticals (ASX:BOT) shares were trading 6.67% lower at $0.042 as of around 3.30 pm on Friday.