Medical dermatology company Botanix Pharmaceuticals (ASX: BOT) revealed trials of its synthetic cannabidiol-based acne product BTX 1503 has demonstrated antibacterial activity against acne.
In the tests, BTX 1503 proved effective against both antibiotic resistant and non-resistant Propionibacterium acne. The testing was undertaken in the United States in a Food and Drug Administration approved laboratory.
Testing pinpointed BTX 1503’s “minimum inhibitory concentration” required for six different Propionibacterium acne strains and four antibiotic-resistant strains. During the testing, BTX 1503 was potent against all the acne strains, with Botanix Pharma reporting “no apparent difference in antibacterial activity, regardless of whether the bacteria was resistant to antibiotics or not.”
According to the company, this is the first time the drug has shown strong antibacterial impact and Botanix Pharma has filed a patent to protect its discovery.
“These latest results have immediate ramifications on Botanix’s clinical development program for acne, providing the company with additional confidence of achieving a positive outcome,” Botanix Pharma executive director Matt Callahan said.
“Combined with our proprietary Permetrex drug delivery technology, BTX 1503 effectively delivers the levels of synthetic cannabidiol required to achieve ideal antibacterial effects to the target skin layers, where the bacteria reside,” Mr Callahan added.
The four main causes of acne include Propionibacterium strains colonising hair follicles, overproducing skin sebum (oil), abnormal proliferation of keratinocytes and inflammation.
Previously published data has shown synthetic cannabidiol can help moderate sebum production, keratinocytes and inflammation. However, Botanix Pharma’s BTX 1503 is the first drug that can attack those factors and provide antibacterial activity on the Propionibacterium hair follicle colonisation.
“This multi-pathogenic ingredient, combined with an established safety profile makes BTX 1503 a very exciting acne treatment candidate,” Dermatology Consulting Service president Dr Zoe Draelos said.
According to Botanix Pharma, most dermatologists prescribe multiple products to treat acne to target the primary four pathogenic factors.
The company claims its BTX 1503’s ability to treat all factors in one product offers a “significant’ opportunity in the prescription acne market which is currently estimated at A$4.5 billion.
Globally, acne affects more than 250 million people, with up to 50 million people suffering in the US, alone.
The current approved treatment Accutane or Roaccutane is taken in tablet form to reduce sebum production. However, it has proven side effects that include the risk of birth defects, lymphoma and suicide.
Botanix Pharma claims its BTX 1503 offers localised delivery through topical application, which has been proven safe in numerous published studies.
The company believes BTX 1503 “will have a significantly better side effect profile than Accutane or Roaccutane”.
Botanix Pharma’s shares soared more than 18% to sit at A$0.069 in early morning trade.