8:12AM Coronado Biosciences announces IND submission for TSO for the Treatment of Moderate to Severe Chronic Plaque Psoriasis (CNDO) 1.72 : Co announced that it has submitted an Investigational New Drug application to the U.S. Food and Drug Administration to begin a Phase 2 clinical study of Trichuris suis ova (TSO) for the treatment of moderate to severe chronic plaque psoriasis.
"We believe psoriasis represents a medical need where a natural immune system regulator like TSO may provide considerable sustained relief to those with the condition," said Dr. Harlan F. Weisman, Coronado's Chairman and CEO. "Psoriasis is a logical human clinical model for immune-mediated diseases because clear, validated and objective endpoints can be established and there are low placebo rates. As such, we believe it is a good disease model in which to determine the potential immunomodulatory effect of TSO."
Coronado is also pursuing the trial based upon encouraging preliminary results from open-label investigator-sponsored trials at two U.S. centers that are currently evaluating multiple doses of TSO in patients with psoriasis. Coronado's proposed Phase 2 trial is a U.S. multi-center, dose-ranging study that will use the Psoriasis Area and Severity Index score from week 0 to week 12 to assess efficacy. Coronado intends to begin enrolling patients in the trial during Q1 of 2014 if the IND application is approved.
