A Dutch biotechnology company has begun enrolling patients in a Phase I/IIa clinical trial to evaluate the efficacy and safety of a topical drug based on bacteriophage Endolysins for the treatment of atopic dermatitis.

Endolysins are bacteriophage enzymes that dissolve bacterial cell walls to release mature phage particles. Endolysins are as specific to specific bacterial strains or species as the bacteriophages they belong to. Scientists have long been exploring the potential use of endolysins as antimicrobial agents: they are specific, do not destroy beneficial microflora, and are active against antibiotic-resistant bacteria. A randomized, double-blind, placebo-controlled, parallel-group, dose-ranging Phase I/IIa study will soon begin to evaluate the efficacy and safety of endolysin XZ.700, specific for Staphylococcus aureus , in patients with mild to moderate atopic dermatitis.

Staphylococcus aureus is now considered as a cause of the development and exacerbation of atopic dermatitis and as an independent cause of itching and irritation.

The study's organizers note that eliminating one bacterial species from the skin microbiome while preserving all beneficial species, including Staphylococcus epidermidis , represents a fundamentally new approach to treating atopic dermatitis. XZ.700 is one of several endolysins in the company's portfolio. Another, SA.100, was approved in 2013 for over-the-counter use against inflammatory skin conditions such as acne, rosacea, and others, and has received numerous positive reviews from doctors and patients.

The planned study, which will involve 48 patients with atopic dermatitis, will examine the safety, pharmacodynamics, and efficacy of XZ.700. Participants will receive a cream containing XZ.700 in three different concentrations or a placebo for 14 days (more information about the study can be found at www.trialregister.nl/trial/8876 ).

In addition to atopic dermatitis, the developers are also considering diabetic ulcers infected with methicillin-resistant staphylococcus (MRSA) as possible indications for the use of XZ.700, as well as cutaneous T-cell lymphoma, in which S. aureus can be a trigger for malignant transformation of the tumor.