TRUST-1's primary endpoint was a 100-point decrease in CDAI and its secondary endpoint was remission (CDAI <150 points). Neither endpoint was met in patients with moderate-to-severe Crohn's disease.
The company says "the lack of overall response was driven by higher-than-expected placebo response rate in patients with CDAI < 290" and although CEO Harlan Weisman is "disappointed with the topline results," he says the company is "encouraged to see TSO's effect in patients with CDAI > 290."
Results from a second interim analysis of a second Phase 2 study are expected in Q4. (PR)
The shares fell 13% Friday.
Update 9:02: Coming off a halt, CNDO is down 68%.