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Botanix Successfully Completes Phase 1 Acne Clinical Trial

July 3, 2017


Earlier today, Botanix Pharmaceuticals Ltd. (ASX:BOT) announced the successful completion of their phase 1 clinical trial of BTX 1503 for the treatment of acne. 


The study looked at the safety, tolerability and pharmacokinetics (movement of the drug through the body) of BTX 1503. BTX 1503 is synthetic cannabidiol delivered topically using the company's proprietary Permetrex delivery system. Permetrex helps to ensure that the majority of the drug stays in the skin rather then the blood stream. Data from the study suggests that only small amounts of the drug entered the blood stream, with the majority remaining in the targeted layers of skin. 


(Image Credit - Botanix Pharmaceuticals)

The study also demonstrated that BTX 1503 has an "excellent safety profile, with little to no skin irritation and no severe adverse events". 


Based on these results, Botanix is finalizing an ethics application to conduct a phase 1b study of BTX 1503 in acne patients this quarter. This study will be the first in the world to test synthetic cannabidiol for the treatment of skin disease. 


Management Commentary


Botanix's Exceutive Director, Matt Callahan 


"We are pleased with the safety and tolerability profile of BTX 1503, which for dermatology products, is often a significant hurdle to further development and commercialization. Generation of this first data set for BTX 1503 is a significant achievement, given that the company has been listed for less than 12 months and we have progressed from formulation development to successful human studies within that period. These results provide confidence to also accelerate our wider pipeline of skin disease products into the clinic and they provide further validation of the potential of the Permetrex skin delivery technology for a range of other applications."


Market Reaction


After the resumption of trading (shares were halted on Friday in anticipation of this announcement), Botanix closed Monday's trading flat at $0.0430 AUD after gaining more than 6% earlier in the day. Trading volume was higher than the company's 30-day average volume. 


View the original ASX announcement here




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