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news.Celsus Therapeutics has reported positive interim results from the first cohort of phase II trial of multi-functional non-steroidal anti-inflammatory cream MRX-6 for the treatment of patients with allergic contact dermatitis (ACD).
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MRX-6 works by inhibiting a steroid target, sPLA2, and through enriching cell surface glycosaminoglycans (GAG).
Celsus chief executive officer Gur Roshwalb said, "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."
A 56% improvement in symptoms from baseline in the MRX-6 treated hand/forearm, compared to a 24% improvement for vehicle (placebo) treated hand/forearm was observed.
Final results from all cohorts of double blind, dose-ranging, vehicle and active control study are expected by end of 2013.
The first part of the two step study enrolled 30 patients at the highest, 2% concentration, of MRX-6.
In the next phase, which will be carried out in the second half of 2013, patients acting as their own controls will receive either MRX-6 (1%, 0.2%) or topical steroids in a random manner, for 21 days.
The difference in percentage change from baseline to day 21 in the Physician Visual Assessment Score for the treated against vehicle hand/forearm is the primary efficacy outcome.
The secondary outcomes include safety and tolerability of the three doses of MRX-6 and efficacy by symptom sub-score.