Botanix Pharmaceuticals (ASX: BOT) is full steam ahead with beginning its atopic dermatitis study in Australia after getting the green light from the Human Research Ethics Committee.
Named BTX 1204, the study utilises Botanix’s Permetrex drug delivery technology to treat people suffering from mild to moderate atopic dermatitis or severe eczema.
A common condition, atopic dermatitis is a chronic, and often relapsing, inflammatory skin disorder, characterised by an inflamed and itchy rash that lasts more than 14 days.
In the United States alone approximately 25 million people suffer from the condition, with up to 18% of sufferers being children and infants.
“BTX 1204 has the potential to provide a new solution to sufferers of atopic dermatitis which is safe and directly addresses the itch and inflammation these patients endure,” Botanix executive director Matt Callahan said.
The phase 1b patient study will be carried out at four dermatology clinics and is due for completion by mid-2018.
This is Botanix’s second study since listing on the ASX 18 months ago.
The first clinical trials were for Botanix’s acne product BTX 1503, which uses the same active drug as BTX 1204.
Because the BTX 1503 study was successful, and the same active drug is used, BTX 1204 has been accelerated into its current clinical trial phase.
In the BTX 1204 study, up to 36 patients will be treated over a four-week period with the Permetrex formulation or a placebo. Patients will be monitored for itch, burning, stinging and improvement of dermatitis lesions.
Scientific data suggests BTX 1204 could inhibit the proliferation of skin cells and immune responses, as well as sooth inflammation.
Once this trial is complete, the company will file an investigational new drug application with the United States Food and Drug Administration to allow BTX 1204 research to progress to a phase 2 safety and efficacy study. The phase 2 study is targeted to begin in the second half of 2018.
According to Botanix, the prescription atopic dermatitis market generates more than US$3.8 billion in sales annually.
In the past 15 years, only one other drug, Crisaborole, has been approved for treating the condition. Botanix claims its BTX 1204 “potentially has a broader mechanism of action than Crisaborole”.