Accelerating clinical program with first human study this month

We just announced that the clinical program for our first acne treatment product, BTX-1503, has been substantially accelerated, with the first human study for that program now scheduled to commence this month.

The safety and irritation studies for BTX-1503 will now be split, so that testing of the Permetrex™ drug delivery is separated from the final formulation.

Synthetic cannabidiol has already been dosed to patients at 20-30 times higher dosages in other studies than what Botanix will be using in its clinical programs, so by establishing the safety and irritation profile of the Permetrex™ formulation first, before combining it with synthetic cannabidiol in the next study, Botanix’s split clinical study will help de-risk the whole program.

We also completed manufacturing of the Permetrex™ formulation at FDA quality standard for our first study last week. Botanix has also just received ethics approval for the study, which will get underway almost immediately, with the data potentially becoming available to the Company before the end of December.

In addition to our acne program, we’re also developing synthetic cannabidiol using Permetrex™ drug delivery technology for the treatment of psoriasis and atopic dermatitis. We’re also actively exploring opportunities to leverage the Permetrex™ technology in a range of other skin treatments that can be developed and commercialised in parallel to BTX-1503, so establishing the basic safety and utility of Permetrex™ as a drug delivery system, provides broader benefits.

Follow-on safety and first acne patient studies for BTX-1503 remain on track to commence in the first half of 2017 and we’re continuing the other required pre-clinical testing and regulatory activities to support those studies.

If you have any questions about ASX announcements or other general questions, feel free to talk to us here or email info [at] botanixpharma.com