Botanix accelerates BTX-1503 development with first human study

Company News

Medical dermatology company Botanix Pharmaceuticals (ASX:BOT) has announced the clinical program for its first product has been substantially accelerated. The first human study will now commence later this month.

The planned safety and irritation studies for BTX-1503, Botanix’s novel formulation of synthetic cannabidiol drug for the treatment of acne, will be split so that the human trials of the Permetrex drug delivery formulation will be separated from the safety studies for the formulation which include synthetic cannabidiol.  

Permetrex is the technology Botanix uses to more effectively deliver drugs into the skin and accordingly makes up the majority of the formulation.

“We are very excited to be able to accelerate the clinical testing of BTX-1503, by now being able to separately test the delivery system from the final formulation which will ultimately include the synthetic cannabidiol drug active,” said Botanix Executive Director Matt Callahan.

“Given that synthetic cannabidiol has already been dosed to patients at 20-30 times higher dosages in other studies than what we will be using in our clinical studies,” he said, “establishing the safety and irritation profile of the Permetrex formulation before we combine it with synthetic cannabidiol in the next study, will help de-risk the whole clinical program.”

Botanix completed manufacturing of the Permetrex formulation for its near term study late last week.  The company said it has also received ethics approval for the study that will commence later in November, with the data potentially becoming available to the before the end of December.

In addition to its acne program, Botanix is also developing synthetic cannabidiol using the Permetrex drug delivery technology for the treatment of psoriasis and atopic dermatitis.  It said it is also exploring opportunities to leverage Permetrex technology in a range of other skin treatments that can be developed and commercialised in parallel to BTX-1503.

Follow-on safety and first acne patient studies for BTX-1503 remain on track to commence in the first half of 2017.