Vercirnon: Phase III data

Data from 118 patients with moderately to severely active CD who had completed 12 weeks of treatment prior to study termination in the double-blind, international Phase III SHIELD-4 trial showed that 56% of patients who received 500 mg vercirnon once daily and 69% of patients who received 500 mg vercirnon twice daily achieved the primary endpoint of clinical response, defined as a reduction in CDAI score of >=100 points from baseline to week 12. In patients who completed the trial, 26% of patients in the once-daily arm and 36% of patients in the twice-daily arm achieved the secondary endpoint of clinical remission, defined as CDAI score of <150 points at week 12.

In all 253 patients in the intent-to-treat (ITT) population, the clinical response rate at week 12 was 25% in the once-daily vercirnon arm and 33% in the twice-daily vercirnon arm. The clinical remission rate at week 12 in the ITT population was 12% in the once-daily vercirnon arm and 18% in the twice-daily vercirnon arm. There were no safety issues observed and gastrointestinal adverse events were not higher in the twice-daily arm compared to the once-daily arm. Data were presented at the American College of Gastroenterology meeting in Philadelphia. ...