Botanix Pharmaceuticals has completed enrolling patients in a Phase Ib trial of BTX 1204 for the treatment of atopic dermatitis patients.
Enrolment of patients was completed ahead of schedule, as Botanix used the same drug and topical application platform as its lead acne product, BTX 1503. This has enabled the company to enrol patients without repeating pre-clinical and clinical testing.
The randomised, placebo controlled trial aims to examine the safety and effects of BTX 1204 in patients with mild-to-moderate atopic dermatitis.
As part of the trial, 36 patients have already received either BTX 1204 or placebo for a four-week treatment period.
The study is currently going on at four dermatology clinics in Australia.
Botanix Pharmaceuticals executive director Matt Callahan said: “Our focus is now to finalise the clinical testing phase of the study and ensure the data is available as planned in 2Q CY2018.”
The BTX 1204 is currently under development by Botanix as a new treatment for mild to moderate atopic dermatitis or eczema, which targets multiple pathologies involved in the development of the disease.
It can be delivered using Botanix’s proprietary Permetrex drug delivery technology.
According to Botanix, BTX 1204 may inhibit the proliferation of skin cells and inhibit immune responses as well as address inflammation and reduce bacterial infection.
Upon completion of the Phase Ib trial, Botanix is set to file an investigational new drug (IND) application with the US Food and Drug Administration (FDA) to initiate a multi-centre Phase II study evaluating the safety and efficacy of BTX 1204 to treat atopic dermatitis.
The proposed trial is expected to begin within this year.