Coronado falls after whipworm product misses in Crohn's
Coronado Biosciences Inc. (NASDAQ:CNDO) fell $3.86 (67%) to $1.91 on Monday after reporting that Trichuris suis ova (TSO) missed the primary endpoint of induction of response at week 12 vs. placebo in the 250-patient Phase II TRUST-I trial to treat Crohn's disease (CD). In the trial, TSO every two weeks also missed the secondary endpoint of induction of remission vs. placebo. Coronado said the lack of overall response was driven by a "higher-than-expected" placebo response rate in patients with a baseline Crohn's Disease Activity Index (CDAI) score of less than 290 points.
Partner Dr. Falk Pharma GmbH (Freiburg, Germany) is evaluating TSO for CD in the European, 240-patient Phase II TRUST-II trial, with data expected this quarter. Coronado said it will analyze the TRUST-I and TRUST-II data to identify next steps for TSO, which comprises ova from T. suis, a porcine helminth. The ova act as a natural immunomodulator to regulate T cells and inflammatory cytokines following colonization of the host intestinal tract. ...