Celgene to present new data on investigational compounds at UEGW, ACG Congress
Celgene announced that findings from clinical trials of investigational compounds GED-0301, ozanimod and RPC4046 will be presented at the United European Gastroenterology Week, October 15-19, in Vienna, Austria. Ozanimod and RPC4046 data will also be included at the American College of Gastroenterology Annual Scientific Meeting, October 14-19, in Las Vegas. Among the data that will be presented is an ongoing, exploratory phase 1b study of GED-0301, an oral compound being investigated for active Crohn's disease. The ongoing study is evaluating the effects of three different regimens of oral GED-0301 on both endoscopic and clinical outcomes in patients with active Crohn's disease in a 12-week treatment phase, followed by an observation phase of up to 52 weeks. The study was designed to further enhance the understanding of GED-0301 activity in a difficult-to-treat, moderate-to-severe patient population. The data were accepted as a late breaking oral presentation at UEG Week. An analysis of the open-label extension of the TOUCHSTONE trial will evaluate the efficacy and safety of daily 1 mg oral ozanimod, an investigational selective S1p 1 and 5 receptor modulator, through week 44 of the open label extension in patients with moderate to severe ulcerative colitis. The 32 week double-blind placebo-controlled phase of TOUCHSTONE evaluated the efficacy and safety of 0.5 mg and 1 mg doses of ozanimod compared with placebo in patients with moderate to severe active ulcerative colitis. Results from this induction and maintenance phase of the trial have been previously reported. The open-label extension phase included TOUCHSTONE participants from all three treatment arms who either did not respond to treatment after the induction phase, relapsed during the maintenance phase or completed the maintenance phase. These results will be featured in an oral presentation at both ACG and UEG Week. Results from the phase 2 HEROES dose-ranging study will evaluate the efficacy and safety of RPC4046 in patients with active eosinophilic esophagitis, a rare but potentially serious allergic/immune disorder for which there are currently no approved treatments. RPC4046 is an investigational humanized monoclonal antibody that binds with high selectivity to both subunits of the IL-13 receptor. The data will be featured in an oral presentation at both ACG and UEG Week.