Results Expected in Fourth Quarter of 2014

NEW YORK, NY, USA and LONDON, UK I August 6, 2014 I Celsus Therapeutics Plc (CLTX), an emerging growth, development-stage biotech company, announced the first patient has been enrolled in its Phase II trial of MRX-6 cream 2% in pediatric patients with atopic dermatitis.

The Company plans to conduct the study in five to six centers in Israel as well as Argentina, enrolling 80 pediatric patients ranging in age from two to 17 years. The trial is a double-blind, parallel-group, vehicle-controlled study to evaluate the safety and efficacy of MRX-6 cream 2% in a pediatric population with mild to moderate atopic dermatitis (Clinicaltrials.gov NCT02031445). The trial will enroll patients 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. Results from this trial are expected in the fourth quarter of 2014.

Pablo Jimenez, M.D., Chief Medical Officer of Celsus Therapeutics, 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.”

Gur Roshwalb, M.D., Chief Executive Officer of Celsus Therapeutics, 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.”

About Celsus Therapeutics Plc

Celsus Therapeutics is an emerging clinical stage company focused on the development of a new class of non-steroidal, synthetic anti-inflammatory drugs termed Multi-Functional Anti-Inflammatory Drugs or MFAIDs. Celsus’s MFAIDs represent a new therapeutic platform for the treatment of a broad array of inflammatory diseases, such as allergies and autoimmune diseases. Presently, the Company’s lead drug candidate in its clinical pipeline is MRX-6, an MFAID topical cream treatment under development for treating skin inflammatory disorders, specifically allergic contact dermatitis and atopic dermatitis, also known as eczema. Other potential treatments in preclinical development include OPX-1 for ocular inflammation, CFX-1 for cystic fibrosis, and MRX-5 for inflammatory bowel disease.

SOURCE: Celsius Therapeutics