Celgene reports Phase 1b data on GED-0301 in Crohn's disease
Celgene announced that data from a phase 1b study evaluating the effects of investigational oral GED-0301, or mongersen, on both endoscopic response and clinical remission in patients with active Crohn's disease will be presented at the United European Gastroenterology Week. A total of 63 patients were enrolled in the study. The population was more diverse than prior GED-0301 studies and included patients with endoscopically confirmed mucosal damage at entry and those who had previous surgeries. Results showed that clinical improvement was seen by week 2, and clinical response and remission rates were highest in the 12-week treatment group at 67 and 48 percent respectively, at week 12. The mean CDAI reduction from baseline at week 12 in the 12-week treatment group was 133 points. Of the patients with evaluable endoscopies at week 12, 37 percent had an endoscopic response, with no meaningful difference across treatment groups. In addition, of those patients with greater endoscopic disease activity at baseline, 63 percent exhibited a reduction greater than or equal to 25 percent in SES-CD score and 31 percent had a reduction of greater than or equal to 50 percent. The rates of adverse events and serious adverse events were low and similar across treatment groups. There were no new safety signals for oral GED-0301 160 mg daily reported in this study.