Press release
Gossamer Bio Announces Presentation of GB004 Phase 1b Clinical Data at United European Gastroenterology Virtual Week 2020 and Additional Program Updates
- Newly disclosed data build on topline results and continue to support GB004’s differentiated approach of targeting epithelial barrier restoration in
About this update from Gossamer Bio, Inc.
[{"type":"text","content":"\n- Newly disclosed data build on topline results and continue to support GB004’s differentiated approach of targeting epithelial barrier restoration in patients with ulcerative colitis -\n\n- GB004 demonstrated superior barrier protection compared to tofacitinib in pre-clinical human monolayer assay -\n\n- SHIFT-UC Phase 2 study active and screening patients for enrollment -\n\n SAN DIEGO--(BUSINESS WIRE)--\nGossamer Bio, Inc. (Nasdaq: GOSS), today announced multiple updates for its GB004 program. GB004 is an oral, gut-targeted HIF-1α stabilizer, designed to promote mucosal healing and resolve local inflammation through a non-immunosuppressive mechanism of action in patients with inflammatory bowel disease.\nThis press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201012005210/en/Median Reduction from Baseline in Fecal Calprotectin (Graphic: Business Wire)\nData Presented at UEGW Virtual 2020\n\nWilliam Sandborn, M.D., Chief of the Division of Gastroenterology of University of California San Diego, presented data at the UEGW Virtual Week 2020 from the successful Phase 1b translational medicine study of GB004 in mild-to-moderate ulcerative colitis, or UC.\n\nThe Phase 1b study evaluated safety, tolerability, and pharmacokinetics over 4 weeks of treatment in patients with active UC despite treatment with 5-aminosalicylate (5-ASA) therapy. In addition to trends disclosed earlier this year, the presentation included newly disclosed data on the reduction of an important inflammatory biomarker in IBD, fecal calprotectin, and the resolution of rectal bleeding, which is considered to be an objective measure of disease activity.\n\n\n\nKey Exploratory Outcomes\n\n\n\n\n\nOutcome / Biomarker (4 weeks)\n\n\n\nPlacebo\n\n\n\nGB004\n\n\n\n\n\nMucosal Healing\n\n\n\n0% (0/11)\n\n\n\n17% (4/23)\n\n\n\n\n\nHistologic Remission\n\n\n\n18% (2/11)\n\n\n\n43% (10/23)\n\n\n\n\n\nResolution of Rectal Bleeding\n\n\n\n36% (4/11)\n\n\n\n57% (12/21)\n\n\n\n\n\nReduction from Baseline in Fecal Calprotectin\n\n\n\n7% (n=11)\n\n\n\n38% (n=21)\n\n\n\n\nGB004’s differentiated mechanism of action was also highlighted in a second poster summarizing data from two pre-clinical studies. In a human monolayer assay, GB004 demonstrated superior protection of barrier integrity compared to tofacitinib, a pan-JAK inhi...