New results from a “world-first” study by Botanix Pharmaceuticals (ASX: BOT) has identified significant anti-inflammatory and immune modulating effects from using cannabidiol (CBD) to treat skin diseases such as psoriasis.
The medical dermatology company today announced interim results for the phase 1b study on its BTX 1308 product, which contains a synthetic form of CBD and is applied directly onto the skin in a topical cream form.
This randomised clinical study is touted as the first one in the world to establish the mechanism of action of CBD in skin disease.
It was conducted in Australia in collaboration with German-based clinical research organisation BioSkin GmbH and Professor Jim Krueger at Rockefeller University in New York, US.
The study involved 15 psoriasis patients who received treatment over a 19-day period either with BTX 1308, an active comparable product or a placebo. Biopsies were then taken from the treated area, as well as the untreated psoriasis and normal skin from the same patient to serve as controls.
According to Professor Krueger, the results showed the effective delivery of CBD to skin layers involved in the pathogenesis of skin disease with the drug triggering “significant alterations in inflammatory and immune response pathways”.
Of particular interest was “BTX 1308’s ability to down-regulate the p38 MAP Kinase pathway”, a key inflammatory disease pathway known to be involved in psoriasis, which Professor Krueger said was something pharmaceutical companies have tried unsuccessfully to target for many years.
“This anti-inflammatory and immune modulation activity potentially makes BTX 1308 a very important treatment option for patients, not only with psoriasis, but other skin diseases that have an inflammation and/or an immune response component,” he said.
A broader impact
According to Botanix, the biopsy data from the study also showed significant down-regulation of genes involved in the atopic dermatitis relevant Th2 response, which supports the positive clinical outcomes already seen in the company’s recently completed BTX 1204 phase 1b atopic dermatitis study.
It also boosts the company’s confidence of success for the BTX 1204 phase 2 study, currently underway.
In addition, Botanix said the new biopsy data is relevant to how another of its products, BTX 1503, may benefit acne.
“The new insights into the mechanism of action for CBD in BTX 1308 provides us with further excitement and justification for our lead programs currently in phase 2 clinical development for acne (BTX 1503) and atopic dermatitis (BTX 1204), that both have significant inflammatory and immune components,” Botanix executive director Matt Callahan said.
He said these phase 2 programs were “well advanced” with study completions approaching in the third and four quarters of this year, respectively.