(ASX: BOT – BOTANIX PHARMACEUTICALS LTD)
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Website: www.botanixpharma.com
Botanix Pharma (ASX:BOT) are dedicated to developing next generation therapeutics for the treatment of serious skin diseases.
Their mission is to improve the lives of patients battling acne, psoriasis and atopic dermatitis, by providing new treatment options for conditions that currently are inadequately addressed or are treated with therapeutics that are burdened with side effects profiles.
BOT are harnessing the untapped potential of a synthetic active pharmaceutical ingredient known as cannabidiol which is currently being studied for the treatment of epilepsy, pain, arthritis and schizophrenia amongst other indications. Botanix is preparing for the first human trials utilizing synthetic cannabidiol in a proprietary drug delivery system (Permetrex™) for direct skin delivery of the therapy.
FDA Clears Development Path for BTX 1503
Botanix successfully completed a Pre-IND meeting with the FDA for BTX 1503 acne product
FDA confirms the proposed development plan and data package presented to support Phase 2 clinical development in the US
Consensus gained on the overall drug development plan required for BTX 1503 to support a New Drug Application
BTX 1503 well-placed to start Phase 2 clinical development in the US in 1H 2018
Philadelphia PA and Sydney Australia, 9 October 2017: Medical dermatology company Botanix Pharmaceuticals Limited (ASX:BOT, “Botanix” or the “Company”) is pleased to announce that it has successfully held a Pre-Investigational New Drug (Pre-IND) meeting with the US Food and Drug Administration’s (FDA) for its lead acne treatment product, BTX 1503. The Pre-IND meeting provided Botanix with an opportunity to seek clarification and support from the FDA on the proposed development plan and data package required to begin Phase 2 clinical studies in the US. It also enabled Botanix to gain confirmation from the FDA on the overall drug development plan required for BTX 1503 to support a New Drug Application (NDA).
Matt Callahan, Executive Director of Botanix stated, “we are very pleased with the outcome of the Pre-IND meeting and now have a clear and rapid path to commence the Phase 2 study program in the US following completion of our Phase 1b study.”
BOT has started to receive some media exposure about their treatment options, and this may be a reason for recent buying interest. http://www.9news.com.au/national/2017/10/20/19/14/cannabis-cream-acne-skin-conditions-melbourne To some it may sound like a dopey idea, but people prone to severe pimple breaks outs could benefit from a new cannabis-derived skin solution.
Top dermatologist Rod Sinclair is conducting a clinical trial of a new topical acne treatment, based on chemicals found in marijuana known as cannabidiols.
"It is an anti-inflammatory. It particularly targets some of the molecules in the inflammatory pathways that are involved in acne and pimples," Professor Sinclair told 9NEWS. The top Melbourne skin expert is studying the effectiveness of the synthetic cannabis solution, manufactured by Australian company Botanix, on patients with moderate to severe acne. "It can really have a profound effect on self-esteem. A lot people with severe acne start to withdraw socially."
Study volunteers apply the tonic to the skin daily, for a month.
Researchers then examine improvements in skin condition, as well as any potential side effects.
