UK-based drug development firm Celsus Therapeutics has started enrolling patients in its Phase II clinical trial of MRX-6 cream 2% for paediatric patients with atopic dermatitis.
Around 80 paediatric patients ranging from two to 17 years of age are expected to be enrolled in the trial, which is scheduled to be carried out in five to six centres in Israel and Argentina.
The trial is designed to evaluate the safety and efficacy of MRX-6 cream 2% for the paediatric population with mild to moderate atopic dermatitis.
In the double-blind, parallel-group, vehicle-controlled trial, patients will be enrolled into a four-week double-blind period, followed by a four-week open label extension for those patients who wish to continue in the trial.
The company intends to report the trial results in the fourth quarter of 2014.
Celsus Therapeutics chief medical officer Dr Pablo Jimenez said: "We are looking forward to undertaking this Phase II trial as the next key step in investigating the safety and efficacy of MRX-6 in children with atopic dermatitis.
"We believe MRX-6 has strong potential to improve the symptoms associated with this condition and the lives of those it affects."
Celsus CEO Gur Roshwalb said: "Our studies to date with MRX-6 have been extremely promising, and we are enthusiastic about developing a new non-steroidal topical therapy for adults and children with atopic dermatitis."
The company is focused on the development of a new class of non-steroidal, synthetic anti-inflammatory drugs, called multi-functional anti-inflammatory drugs (MFAIDs), which represent a new therapeutic platform to treat a broad array of inflammatory diseases such as allergies and autoimmune diseases.
Currently, the company’s lead drug candidate in its clinical pipeline is MRX-6, a MFAID topical cream treatment being developed for the skin inflammatory disorders allergic contact dermatitis and atopic dermatitis, also known as eczema.
Image: Atopic dermatitis of the anterior flextural crease of the elbow. Photo: courtesy of James Heilman, MD.