Celsus Therapeutics has reported positive interim results from the first cohort of its Phase II trial of MRX-6 for the treatment of patients with allergic contact dermatitis (ACD).
The multi-functional non-steroidal anti-inflammatory cream MRX-6, works through the inhibition of sPLA2, inflammation-initiating catalytic enzyme, and through enriching cell surface glycosaminoglycans (GAG).
Celsus Therapeutics chief executive officer Gur Roshwalb said the results demonstrate that MRX-6 seems to have a clinical benefit in the treatment of contact dermatitis.
"Hands treated with MRX-6 demonstrated clinically meaningful improvement. We currently anticipate filing a US IND in 2014 and initiating US Phase II trials for psoriasis and atopic dermatitis in the second half of 2014," Roshwalb said.
"We believe these data validate our platform of targeting inflammation upstream of the eicosanoid pathway, but without the metabolic and psychiatric side-effects associated with steroids."
The results show a 56% improvement in symptoms from baseline in MRX-6-treated hands and forearms, compared to a 24% improvement for vehicle (placebo) treated hands and forearms.
Final results from all cohorts of the doubl- blind, two-step dose-ranging, vehicle and active control study are expected by end of 2013.
The first part of the study enrolled 30 patients at the highest concentration of MRX-6, 2%. The next phase is to be carried out in the second half of 2013.
In the latter phase of the study, patients will again act as their own controls but will receive in a random manner either MRX-6 (1%, 0.2%) or topical steroids, for 21 days.
The primary efficacy outcome is defined as the difference in percentage change from baseline to day 21 in the Physician Visual Assessment Score for the treated versus vehicle hands and forearms.
The secondary outcomes are evaluation of the safety and tolerability of the three doses of MRX-6 and efficacy by symptom sub-score.