Botanix Pharmaceuticals (ASX:BOT) has received approval to conduct the first clinical study of synthetic cannabidiol for acne using the company’s BTX 1503 product.
The approval was granted by the Human Research Ethics Committee (HREC) of the Queensland Institute for Medical Research.
Botanix’s shares were last trading 10% higher intra-day, at $0.064.
The recruitment of volunteers for the safety and pharmacokinetic studies will begin shortly in Queensland, and the data will be available in Q2 CY2017.
Botanix continues to rapidly advance in parallel preparation for the follow-on pilot study in acne patients, and will commence the study following review of the data from these first studies.
Importantly, these studies will be the first to be conducted anywhere in the world using synthetic cannabidiol for the treatment of a skin disease, with oversight from a regulator.
The approval to commence human studies comes less than nine months after Botanix’s listing on the ASX and the initiation of formulation development and pre-clinical testing activities.
Botanix’s clinical studies will initially be conducted under the Therapeutic Goods Administration’s (TGA’s) regulatory framework.
The company will then conduct studies under the U.S. Food and Drug Administration (FDA) drug approval process.
The compliance with these regulatory processes will allow Botanix products to be marketed as prescription products and allow them to be reimbursed through health insurance systems.
Achieving FDA approval for BTX 1503 unlocks a significant market, as prescription sales of acne products in the U.S. alone exceed $4.5 billion per annum.
Furthermore, the rapid advancement of BTX 1503 into the clinic provides a clear path for Botanix’s two pipeline products for the treatment of psoriasis and dermatitis.