ChemoCentryx Reports GSK's Top-Line Results From SHIELD-1 Phase III Trial

(RTTNews) - ChemoCentryx, Inc. (CCXI) reported that GlaxoSmithKline (GSK.L, GSK) announced that the first of four Phase III studies, the SHIELD-1 study, investigating vercirnon, an inhibitor of the chemokine receptor known as CCR9, in patients with moderate-to-severe Crohn's disease did not meet the primary endpoint of improvement in clinical response and the key secondary endpoint of clinical remission. The rates of serious adverse events and withdrawals due to adverse events were similar among all treatment groups including the placebo group, with a trend in dose-dependent increases in overall adverse event rates.

GSK indicated its plans to continue to explore the safety and efficacy results to inform decisions on the clinical development program for vercirnon. New recruitment and dosing in the ongoing program has been suspended pending further review of the SHIELD-1 results.

According to Thomas Schall, PhD, President and Chief Executive ChemoCentryx, "While we are clearly very disappointed with the results from the GSK SHIELD-1 study, we await GSK's decision on the future development plan for the vercirnon program following their further analysis of their data."

SHIELD-1 is a randomized, double-blind, placebo-controlled trial that assessed the efficacy and safety of two doses of vercirnon compared to placebo over 12 weeks in 608 adult patients with moderate-to-severe active Crohn's disease.

The primary endpoint was the proportion of patients achieving clinical response, defined as a decrease in Crohn's Disease Activity Index score of at least 100 points at 12 weeks; while clinical remission at 12 weeks was evaluated as a key secondary endpoint. The trial was conducted at over 200 study centers worldwide.