FibroGen Concludes Dosing In Late-Stage Blood Cell Disorder Study, Sees Top-line Data In H1 2023

FibroGen, Inc. FGEN has completed patient enrollment for MATTERHORN, a Phase 3 clinical study of roxadustat for treatment of anemia in patients with lower risk transfusion-dependent myelodysplastic syndromes (MDS). MATTERHORN study is a Phase 3 trial evaluating the efficacy and safety of roxadustat for treatment of anemia in patients with lower risk transfusion-dependent myelodysplastic syndromes. A total of 141 subjects have been enrolled in the study. The primary endpoint of the study is transfusion independence for ≥ 56 consecutive days in the first 28 weeks of treatment, while the main secondary endpoint is reduction of red blood cell transfusion. Mark Eisner, Chief Medical Officer, stated, "We are very pleased to complete enrollment of this Phase 3 study of roxadustat for the treatment of anemia in patients with lower risk MDS. Patients living with MDS have limited treatment options for their anemia, and MATTERHORN evaluates roxadustat as a potential new treatment that can reduce the burden of blood transfusions. On behalf of the entire study team, we would like to extend our gratitude to the patients, caregivers, investigators, and study staff for their commitment to this study." Myelodysplastic syndromes (MDS) are a group of disorders characterized by poorly formed or dysfunctional blood cells, resulting in chronic anemia in most patients. The company anticipates top-line data readout from the study in first half of 2023.  Price Action: FibroGen closed Thursdays trading at $13.55