Bowel Disease Therapy Fails Phase II Study
Porcine whipworm eggs are no better than placebo (October 14)
Disappointing results have been reported from a phase II clinical trial evaluating TSO (Trichuris suis ova, Coronado Biosciences) in patients with moderate-to-severe Crohn’s disease (CD).
TSO, the microscopic eggs of the porcine whipworm, is an investigational, orally administered, natural immunomodulator that regulates T-cells and pro-inflammatory cytokines.
The phase II TRUST-I study did not meet its primary endpoint of improving response, defined as a 100-point decrease in the Crohn’s Disease Activity Index (CDAI), nor the key secondary endpoint of remission, defined as achieving a CDAI score of less than 150 points.
In the overall patient population, the response rate of patients treated with TSO was not different from that of patients given placebo. In a predefined subset analysis, TSO showed a non-significant improved response in patients with CDAI scores greater than 290.
TRUST-I was a randomized, double-blind, placebo-controlled, U.S. study designed to evaluate the safety and efficacy of TSO in patients with CD. A total of 250 patients with moderate-to-severe CD were randomly assigned to receive either 7,500 ova (n = 125) or placebo (n = 125) once every 2 weeks for 12 weeks. The study’s primary endpoint was the induction of a response at 12 weeks, and the induction of remission was a key secondary endpoint.
Patients who completed the study had the option of enrolling in a 12-week open-label extension trial. All patients in the extension trial receive 7,500 ova once every 2 weeks.
Source: Coronado Biosciences; October 14, 2013.