Coronado reports disappointing results from its Crohn’s disease trial

US biopharma company Coronado Biosciences (Nasdaq: CNDO) has announced that TSO (Trichuris suis ova or CNDO-201) did not meet its primary endpoint of improving response in a trial of 250 patients with moderate-to-severe Crohn's disease. The company’s shares dropped nearly 70% to $1.90 on the news yesterday.

The company released the results from TRUST-I, its Phase II clinical trial. The drug did not meet the response target, defined as a 100-point decrease in the Crohn's Disease Activity Index (CDAI), nor the key secondary endpoint of remission, defined as achieving CDAI <150 points. In addition, in the overall patient population, response rate of patients on TSO did not separate from that of placebo. The randomization was stratified by disease activity as measured by CDAI. In the corresponding pre-defined subset analysis, TSO showed a non-significant improved response in patients with CDAI > 290. The lack of overall response was driven by higher-than-expected placebo response rate in patients with CDAI < 290.

Will assess most appropriate development path