FibroGen Announces Positive First Results from Phase 2 Clinical Trial of Roxadustat for Treatment of Chemotherapy-Induced Anemia | Small molecules
FibroGen Announces Positive First Results from Phase 2 Clinical Trial of Roxadustat for Treatment of Chemotherapy-Induced Anemia
Category: Small Molecules
Posted on Thursday, August 26, 2021 09:35
SAN FRANCISCO, CA, USA I August 25, 2021 I FibroGen, Inc. (NASDAQ: FGEN) today announced the first positive results of WHITNEY, the Company’s Phase 2 clinical study of roxadustat, an oral small-molecule inhibitor of hypoxia-inducible factor prolyl hydroxylase (HIF-PHI), first in its class, for the treatment of chemotherapy-induced anemia (AIC).
WHITNEY is an open-label, phase 2 study investigating the efficacy and safety of roxadustat for the treatment of anemia in patients receiving concomitant chemotherapy treatment for non-myeloid malignancies. The primary efficacy endpoint of maximal change in hemoglobin within 16 weeks from baseline without red blood cell transfusion was met.
“Roxadustat is a promising new approach for the treatment of chemotherapy-induced anemia, which complicates the treatment of many cancer patients,” said Mark D. Eisner, MD, MPH, medical director of FibroGen. “Further studies will be needed to assess whether roxadustat can safely and effectively treat this important type of anemia. “
In WHITNEY, ninety-two patients with a non-myeloid malignancy (solid tumor) with a hemoglobin level of 10 g / dL or less were included. Patients received an initial dose of roxadustat of 2.0 mg / kg or 2.5 mg / kg, three times per week (TIW), for a treatment period of 16 weeks, with an additional follow-up period of 4 weeks . Doses could be titrated every 4 weeks.
Roxadustat was generally well tolerated and there were no substantial differences in treatment-related adverse events (TREs) between the arms with different starting doses.
The full results of the study will be presented at a medical meeting later this year.
For more information on this study, please visit www.clinicaltrials.gov (NCT04076943).
About chemotherapy-induced anemia
Although chemotherapy-induced anemia is one of the most common side effects of chemotherapy, it often goes unrecognized and is often undertreated. AIC can negatively affect the long-term outcome of patients, as anemia limits both the quality of life and the effectiveness of chemotherapy treatment. The incidence and severity of CIA depend on various factors. This includes the type of cancer and the treatment, including the type of chemotherapy, timing and intensity of treatment. It also depends on whether the patient has ever received myelosuppressive chemotherapy, radiation therapy, or both. It is estimated that 30 to 90% of cancer patients receiving chemotherapy develop anemia1. About 650,000 cancer patients undergo chemotherapy each year in the United States2.
Roxadustat, an oral drug, is the first in a new class of drugs comprising HIF-PH inhibitors that promote erythropoiesis, or the production of red blood cells, by increasing the endogenous production of erythropoietin, the improved iron absorption and mobilization and downregulation of hepcidin. Roxadustat is also in clinical development for chronic kidney disease anemia (CKD) and anemia associated with myelodysplastic syndromes (MDS).
Roxadustat is approved in European Union (EU) member states, including countries in the European Economic Area (EEA), as well as in Japan, China, Chile and South Korea for the treatment of CRF anemia in adult patients on dialysis (DD) and not on dialysis (NDD). Several other license applications for roxadustat have been submitted by partners, Astellas and AstraZeneca to regulatory authorities around the world, and are currently under review.
Astellas and FibroGen are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia in territories such as Japan, Europe, Turkey, Russia and the Commonwealth of Independent States, the Middle East and the ‘South Africa. FibroGen and AstraZeneca are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia in the United States, China, other markets in the Americas, Australia / New Zealand and South East Asia.
FibroGen, Inc. is a biopharmaceutical company engaged in the discovery, development and commercialization of a pipeline of world-class therapeutics. The Company applies its pioneering expertise in the biology of hypoxia inducible factor (HIF) and connective tissue growth factor (CTGF) to advance innovative drugs for the treatment of unmet need. The Company is currently developing and marketing roxadustat, a small molecule oral inhibitor of prolyl hydroxylase HIF activity, for anemia associated with myelodysplastic syndromes (MDS) and for anemia induced by chemotherapy (CIA). Pamrevlumab, an anti-CTGF human monoclonal antibody, is in clinical development for the treatment of unresectable locally advanced pancreatic cancer (LAPC), Duchenne muscular dystrophy (DMD) and idiopathic pulmonary fibrosis (IPF) . For more information, please visit www.fibrogen.com.
THE SOURCE: FibroGen