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Gossamer Bio reports clinical, financial, and corporate updates tied to seralutinib, its investigational inhaled tyrosine kinase inhibitor for pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease. Recurring developments include Phase 3 study results, regulatory pathway updates, collaboration activity with Chiesi Group, quarterly financial results, and capital allocation updates.
Company news also covers Nasdaq Rule 5635(c)(4) employment inducement grants under the 2023 Employment Inducement Incentive Award Plan, investor conference participation, and business development or resource-allocation actions related to its pulmonary hypertension strategy.
Gossamer Bio (Nasdaq: GOSS) announced it will present data on GB1275 at the 35th Annual Meeting of the Society for Immunotherapy of Cancer (SITC), held virtually from November 9-14, 2020. The presentation will include clinical and biomarker data from the ongoing Phase 1/2 trial, KEYNOTE-A36, focusing on advanced solid tumors. Two key posters will be presented by Dr. Johanna Bendell and Dr. Wells Messersmith, detailing the preliminary results and immune biomarker evaluations of GB1275, a CD11b modulator.
Gossamer Bio, Inc. (Nasdaq: GOSS) announced topline results from its Phase 2b LEDA trial for GB001 in patients with moderate-to-severe eosinophilic asthma and the Phase 2 TITAN trial for chronic rhinosinusitis. While the primary endpoint in the LEDA trial was not met, the results showed consistent numeric reductions in asthma worsening across all doses. Statistically significant improvements were noted in the secondary endpoint of time to first asthma worsening. The TITAN trial did not achieve its endpoints, leading to the decision not to pursue further development in that area.
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.
Gossamer Bio, Inc. (Nasdaq: GOSS) will present data on GB004 at the upcoming United European Gastroenterology Virtual Week 2020, from October 11-13. The oral presentation by Dr. William Sandborn will discuss clinical data from the completed Phase 1b trial for patients with active mild-to-moderate ulcerative colitis. Two sessions will showcase GB004's safety and protective effects on epithelial cells, signaling its potential in treating inflammatory bowel disease.