Coronado Biosciences Announces Independent Data Monitoring Committee Recommends Discontinuing Falk Phase 2 Trial of TSO in Crohn's Disease
Coronado Biosciences (NASDAQ: CNDO) today announced that it has been informed by Dr. Falk Pharma GmbH (Falk), its development partner, that an Independent Data Monitoring Committee (IDMC) has conducted a second interim analysis of clinical data from approximately 240 patients who have completed 12 weeks of treatment in Falk's Phase 2 clinical trial in Europe evaluating Trichuris suis ova (TSO) in Crohn's disease. The committee recommended that the trial be stopped due to lack of efficacy and noted no safety concerns. Falk has advised Coronado that it is adopting the committee's recommendations and discontinuing the study.
"We are not surprised by these results, given the disappointing data from our TRUST-I study," said Dr. Harlan F. Weisman, Coronado's Chairman and CEO. "We believe TSO has therapeutic potential in other diseases and will continue to work diligently to advance its development for the treatment of autoimmune diseases and to develop CNDO-109 for the treatment of cancer."
The Falk trial, also known as the TRUST-II study, is a double-blind, randomized, placebo-controlled, multi-center Phase 2 study to evaluate