GlaxoSmithKline has suspended recruitment in a late-stage clinical programme assessing its investigational Crohn’s drug vercirnon, after the first batch of data failed to impress.
The UK drug giant said the first of four Phase III trials failed to meet its primary endpoint of improving clinical response and missed the key secondary endpoint of clinical remission.
Consequently, the group has put a hold on both new enrolment and dosing in its programme pending further review of the trial’s results.
SHIELD-1 – a randomised, double-blind, placebo-controlled study – was designed to assess the efficacy and safety of the investigational CCR9 antagonist in 500mg once daily and 500mg twice daily regimens against a placebo.
On the safety side, the study, which included 608 patients with moderately-to-severely active Crohn’s disease not adequately controlled by conventional therapies, showed that serious adverse events and withdrawals were similar between the treatment groups.
However, there was a trend for dose-dependent increases in overall adverse event rates, GSK noted.
Paul-Peter Tak, Senior Vice President, GSK Immuno-inflammation R&D, said the results were “disappointing”, but that the data will be further explored “to determine the way forward”.
