GlaxoSmithKline (GSK) announced today that the first of four Phase III studies, the SHIELD-1 study, investigating vercirnon - an investigational CCR9 antagonist - in adult patients with moderately-to-severely active Crohn's disease did not achieve 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 the treatment groups, but there was a trend for dose-dependent increases in overall adverse event rates. GSK will continue to explore the safety and efficacy results to inform decisions about the clinical development programme for vercirnon. New recruitment and dosing in the ongoing clinical programme has been suspended pending further review of the SHIELD-1 results.
"The results from the SHIELD-1 study are clearly disappointing but we are committed to further explore the data to determine the way forward to help patients with this chronic debilitating gastrointestinal disease," commented Paul-Peter Tak, M.D., Ph.D., Senior Vice President, GSK Immuno-inflammation R&D.
Vercirnon is not approved or licensed for use anywhere in the world. The full results from the SHIELD-1 study will be submitted to a forthcoming scientific congress and peer-reviewed scientific journal.
About SHIELD-1 study
SHIELD-1 is a randomised, double-blind, placebo-controlled study that evaluated the efficacy and safety of two doses (500 mg once daily and 500 mg twice daily) of vercirnon compared to placebo over 12 weeks in 608 adult patients with moderately-to-severely active Crohn's disease.
The study was conducted in patients who were not adequately controlled with conventional therapy, and included patients who did not respond to tumour necrosis factor-alpha (TNF-