Gossamer Bio Announces Presentation of GB004 Phase 1b Clinical Data at United European Gastroenterology Virtual Week 2020 and Additional Program Updates
Gossamer Bio (Nasdaq: GOSS) announced updates on its GB004 program targeting inflammatory bowel disease. At the UEGW Virtual Week 2020, data were presented from a Phase 1b study of GB004 in mild-to-moderate ulcerative colitis, showing safety and promising efficacy. Key outcomes included 17% mucosal healing and significant reduction in the inflammatory biomarker fecal calprotectin (38% reduction). The company is now screening patients for a global Phase 2 study (NCT04556383) with a primary endpoint of clinical remission at week 12, involving up to 195 subjects.
- GB004 demonstrated 17% mucosal healing in UC patients, compared to 0% in placebo.
- 43% of patients achieved histologic remission with GB004, versus 18% with placebo.
- Significant reduction in fecal calprotectin by 38% in GB004 group.
- Initiation of Phase 2 study (NCT04556383) for GB004 with 195 patients expected.
- None.
SAN DIEGO--(BUSINESS WIRE)--Gossamer 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.
Data Presented at UEGW Virtual 2020
William 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.
The 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.
Key Exploratory Outcomes |
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Outcome / Biomarker (4 weeks) |
Placebo |
GB004 |
Mucosal Healing |
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Histologic Remission |
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Resolution of Rectal Bleeding |
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Reduction from Baseline in Fecal Calprotectin |
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GB004’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 inhibitor approved for the treatment of moderate-to-severe UC. In a separate mouse organoid study, GB004 induced HIF-1α-dependent genes, including barrier function genes such as Claudin 1, which were elevated in patients in the Phase 1b trial, further validating GB004’s mechanism of action.
Both posters presented at UEGW Virtual Week 2020 and a replay of Dr. Sandborn’s presentation can now be viewed in the “Posters & Publications” of Gossamer’s website at https://www.gossamerbio.com/pipeline/posters-and-publications/.
GB004 SHIFT-UC Phase 2 Study in Patients with Active Mild-to-Moderate UC
Gossamer has begun screening patients in a global Phase 2 study of GB004 in patients with active ulcerative colitis despite treatment with 5-ASA (NCT04556383). Up to 195 subjects are expected to be enrolled, randomized evenly across two dose arms of GB004 and placebo.
The primary endpoint of the study is clinical remission at week 12. Patients will continue blinded treatment through week 36, after which they will have the option to roll onto an open-label extension. Additional endpoints such as mucosal healing, histologic remission, clinical response, and disease clearance also will be assessed.
About Gossamer Bio
Gossamer Bio is a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology. Its goal is to be an industry leader in each of these therapeutic areas and to enhance and extend the lives of patients suffering from such diseases.
Forward-Looking Statements
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