Coronado Biosciences,
Inc. CNDO, a biopharmaceutical company focused on the development of
novel immunotherapy biologic agents for the treatment of autoimmune diseases
and cancer, today announced top-line results from TRUST-I, its Phase 2
clinical trial evaluating TSO (Trichuris suis ova or CNDO-201) in 250 patients
with moderate-to-severe Crohn's disease.
The 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 CDAI < 150
points. 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.
"While we are disappointed with the topline results, we are encouraged to see
TSO's effect in patients with CDAI > 290. These results support the potential
of TSO to regulate the immune system in patients with Crohn's disease,
particularly those with higher level of disease severity," said Dr. Harlan F.
Weisman, Coronado's Chairman and CEO. "We look forward to further analyzing
the data from TRUST-I, along with the anticipated data from Dr. Falk Pharma's
TRUST-II study in Crohn's disease, to identify the most appropriate
development path for TSO."
TSO was safe and well-tolerated, and adverse events were balanced between the
TSO and the placebo group. The most common adverse event reported was
abdominal pain and occurred in 11% of both TSO and placebo groups. Detailed
trial results will be reported at upcoming medical and scientific meetings.
TRUST-I is a randomized, double-blind, placebo-controlled, U.S. multicenter
study designed to evaluate the safety and efficacy of TSO in Crohn's disease.
The trial enrolled and randomized 250 patients with moderate-to-severe Crohn's
disease to receive either 7500 ova (n=125) or placebo (n=125) once every 2
weeks, for 12 weeks. The primary endpoint for the study is induction of
response at 12 weeks, with induction of remission being a key secondary
endpoint. Patients who completed the TRUST-I study had the option of enrolling
in a 12-week open-label extension trial. All patients in the extension trial
receive 7500 ova once every 2 weeks.
Coronado's development partner for TSO in Crohn's disease, Dr. Falk Pharma
GmbH, is conducting TRUST-II, a phase 2, double-blind, randomized,
placebo-controlled, multi-center study in Europe to evaluate the efficacy and
safety of three different dosages of TSO in active Crohn's disease. The
results from a second interim analysis are expected in the fourth quarter of
2013.
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