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

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

FibroGen 在後期血細胞疾病研究中結束給藥,在 2023 年上半年看到頂線數據
Benzinga Real-time News ·  2022/08/26 20:15

FibroGen, Inc. (NASDAQ: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

FibroGen, Inc.(納斯達克股票代碼:FGEN)已完成MATTERHORN的患者入組。MATTERHORN是一項羅沙司他用於治療低風險輸血依賴性骨髓增生異常綜合徵(MDS)患者貧血的3期臨床研究。MATTERHORN研究是一項3期試驗,旨在評估羅沙司他治療低風險輸血依賴性骨髓增生異常綜合徵患者貧血的療效和安全性。該研究共招收了141名受試者。該研究的主要終點是在治療的前28周內連續超過56天的輸血獨立性,而主要的次要終點是減少紅細胞輸血。首席醫學官馬克·艾斯納表示:“我們很高興完成這項針對roxadustat的3期研究的入組,該研究用於治療風險較低的MDS患者的貧血。MDS患者的貧血治療選擇有限,MATTERHORN將羅沙司他評估爲一種潛在的新療法,可以減輕輸血負擔。我們謹代表整個研究小組向患者、護理人員、研究人員和研究人員對這項研究的承諾表示感謝。”骨髓增生異常綜合徵 (MDS) 是一組以血細胞形成不良或功能失調爲特徵的疾病,導致大多數患者出現慢性貧血。該公司預計,該研究將在2023年上半年讀出第一線數據。價格走勢:FibroGen週四收於13.55美元

譯文內容由第三人軟體翻譯。


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