Teenagers won’t just be smoking cannabis on the sly in the future — they could be openly smearing it on their face to prevent acne.
Aussie company Botanix is developing the first new acne treatment in 20 years that aims to fight pimples using a synthetic version of cannabidiol.
However, it won’t give teens a high because it uses the nonpsychotropic molecules of cannabis.
Botanix yesterday reported to the Australian Stock Exchange its first safety study on humans of the cannabis compound BTX 1503.
The study found the compound “has an excellent safety profile, with little to no skin irritation and no severe adverse events were recorded”.
The most common adverse effect was skin dryness.
Botanix executive director Matthew Callahan said phase 2 clinical trials of the treatment will begin on acne patients in Australia within months.
Existing acne treatments involve antibiotics and a drug called Roaccutane which has been linked to birth defects and in the US requires users to be put on a suicide watch program.
In 2014, a German study at Lubeck University found cannabidiol controlled oil production in the sebaceous gland tissue and also had anti-inflammatory effects.
“Collectively, our findings suggest that, due to the combined lipostatic, antiproliferative and anti-inflammatory effects, CBD has potential as a promising therapeutic agent for the treatment of acne vulgaris,” the study found.
Mr Callahan said there were plenty of reports of people using crude extracts of the cannabis plant to treat acne and it having a positive effect but no one knew which molecules made the difference.
His company tested a number of chemicals in the cannabis plant to isolate the molecule that was active against acne and then made a synthetic version.
The chemical was then combined with a special delivery system called permetrex than ensures the substance gets to the right layers of the skin and stays there to do its work instead of being absorbed into the body.
Callahan is urging the Federal Government to put up $10 million to develop the infrastructure for later stage clinical trials in Australia to keep the money from breakthroughs like his in the country.
Once data from initial clinical studies has been gathered, Botanix plans to shift most of the clinical development of the treatment to the US to seek FDA approval and launch its drug there.
“Australia does not have the infrastructure base to run larger clinical studies,” he said.
“We need people who have experience running and co-ordinating later stage clinical trials, who can find the doctors and get them involved, train the doctors and introduce them to the studies.”
The government is spending hundreds of millions of dollars on venture capital to help Australian medical research ideas get off the ground but without the later stage clinical trial expertise ideas will still go overseas, he said.
“Just $5-10 million would make a massive difference,” he said.
“Australia remains a fantastic regulatory environment to get new products into the clinic and accelerate them into early patient studies.
“But when it comes to Phase 2 and Phase 3 studies that can involve hundreds of patients and millions of dollars of investment, the infrastructure and experience base is just not there to comfortably locate these later-stage, more profitable studies, in Australia.
“I think the Government should take a leaf out of Japan’s book with the new industries they have created in regenerative medicine.
“Once safety is proven, the drug or device is provisionally approved and can be accessed by patients while later stage studies are conducted in parallel.”
Professor Rodney Sinclair from the Australasian College of Dermatologists says the acne treatment faces many hurdles before it comes to market.
“Having demonstrated there are cannabinoid receptors in the oil glands and that you can produce a biological change in them, now you’ve got to develop a cream to penetrate to the right level and have an effect on acne,” he said.
“That is the point where it will get exciting,” he said.