Botanix Pharmaceuticals (ASX: BOT) has enrolled its first patients for its phase 1b clinical trial into its proprietary BTX 1204 treatment on atopic dermatitis sufferers.
Atopic dermatitis is a common chronic condition characterised by an inflamed and itchy rash that lasts more than 14 days.
Using its patented Permetrex delivery technology, Botanix Pharmaceuticals developed BTX 1204 to treat patients with mild to moderate atopic dermatitis and serious eczema. Up to 36 patients will be enrolled in the trial, which will be carried out across four Australian dermatology clinics.
“There is substantial interest in this new therapy given the established safety profile of synthetic cannabidiol and the demonstrated anti-inflammatory and anti-infective properties of the drug,” Botanix Pharmaceuticals executive director Matt Callahan said.
“BTX 1204 has the potential to provide a new solution to sufferers of atopic dermatitis which is safe and directly addresses the inflammation and itch these patients endure,” he said.
This phase of the trial is randomised, double-blind, placebo controlled which aims to evaluate the safety and tolerability of BTX 1204 in study subjects with mild-to-moderate atopic dermatitis.
The treatment period will be over a four weeks, with trial subjects receiving a placebo or BTX 1204.
During the study, patients will be monitored for safety, skin tolerability and assessed for BTX 1204’s impact on lesions, itching, burning and stinging compared to the placebo.
Phase 1b results are anticipated to be released early in the second quarter of next year. Once complete, Botanix Pharmaceuticals plans to file an investigational new drug application with the US Food and Drug Administration. If granted, this will enable Botanix Pharmaceuticals to proceed with a larger Phase 2 BTX 1204 safety and efficacy study in the US during the second half of next year.
To-date, data indicates BTX 1204 could inhibit cell proliferation and immune responses as well as sooth inflammation associated with atopic dermatitis.
Atopic dermatitis affects about 25 million people in the United States, with infants and children accounting for 18% of sufferers.
With its BTX 1204, Botanix Pharmaceuticals is targeting the prescriptions atopic dermatitis market in the country, which generates almost US$4 billion in annual sales.
Since listing 18 months ago, the BTX 1204 trial is the company’s second study, with initial trials surrounding Botanix Pharmaceuticals’ BTX 1503 acne product which also incorporates the Permetrex delivery technology.