Celsus Therapeutics Receives FDA Allowance of IND in Atopic Dermatitis

Celsus Therapeutics will expand its clinical program in atopic dermatitis in the US, now that the FDA has allowed its Investigational New Drug Application (IND) for the clinical development of MRX-6 Cream 2% in patients with atopic dermatitis.

The Company plans to initiate enrollment of a Phase II double blind, vehicle controlled, dose ranging trial of MRX-6 cream testing 0.1%, 1% and 2% vs vehicle in the first quarter of 2015. 

"We are very excited to expand our Phase II program into the United States," said Dr. Gur Roshwalb, Chief Executive Officer of Celsus Therapeutics. "Along with the positive results from our earlier clinical trials in allergic contact dermatitis, and our ongoing trial in pediatric atopic dermatitis, this trial will help us better understand the effect of MRX-6 in skin inflammation and prepare us for our U.S. Phase III clinical program, which we expect to begin in late 2016. We believe MRX-6 will provide a safe and effective alternative to topical steroids and calcineurin inhibitors for children and adults suffering from atopic dermatitis." 

The Phase II trial will test three doses (0.1%, 1% and 2%) versus vehicle to evaluate the safety and efficacy of MRX-6 cream in mild to moderate atopic dermatitis. The trial will enroll 168 patients into a four-week double-blind period. Results from this trial are expected in the first quarter of 2016.