Press release
Gossamer Bio Announces Fourth Quarter and Full-Year 2022 Financial Results and Provides Business Update
- FDA Feedback on Seralutinib Phase 3 Clinical Trial Received; Expected to Commence in the Second Half of 2023 - - Topline Data from TORREY Study Open-Label
About this update from Gossamer Bio, Inc.
[{"type":"text","content":"\n- FDA Feedback on Seralutinib Phase 3 Clinical Trial Received; Expected to Commence in the Second Half of 2023 -\n\n- Topline Data from TORREY Study Open-Label Extension Expected in Mid-2023 -\n\n- Enrollment in GB5121 Phase 1b/2 Clinical Trial in PCNSL Paused -\n\n- Cash, cash equivalents and marketable securities totaled $256 million at year-end 2022 -\n\n SAN DIEGO--(BUSINESS WIRE)--\nGossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, today announced its financial results for the fourth quarter and year ended December 31, 2022 and provided a business update.\n\nClinical-Stage Product Candidate Updates\n\nSeralutinib (GB002): Inhaled PDGFR, CSF1R and c-KIT Inhibitor for Pulmonary Arterial Hypertension (PAH)\n\n\nUpon completion of the 24-week blinded portion of the Phase 2 TORREY Study, patients were able to enroll into an open-label extension trial. We anticipate reporting results from this ongoing open-label extension trial in the middle of 2023.\n\n\nWe expect to commence a Phase 3 PAH clinical trial in the second half of 2023. The planned Phase 3 clinical trial will be a randomized, double-blind, placebo-controlled, global clinical trial in PAH patients. Patients will be randomized to receive either seralutinib or placebo, in addition to their background PAH therapies.\n\n\nBased on FDA feedback, we expect to test a single dose of 90 mg twice daily in the planned PAH Phase 3 clinical trial, and we expect the primary endpoint of the trial to be change in six-minute walk distance from baseline. However, the final trial design is subject to further feedback from global regulatory authorities.\n\n\nGB5121: Oral, CNS-Penetrant BTK Inhibitor for Primary CNS Lymphoma (PCNSL)\n\n\nBased upon the benefit / risk profile observed to date and a prioritization of resources to support the seralutinib program, Gossamer has decided to pause enrollment in the Phase 1b/2 STAR CNS study.\n\n\nGossamer plans to discuss available data with the study’s Data Review Committee to determine next steps.\n\n\nFinancial Results for Quarter and Full Year Ended December 31, 2022\n\n\nCash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as o...