Benzinga | Aug 25, 2021 07:01AM EDT

FibroGen Primary Efficacy Endpoint In Phase 2 Clinical Trial Of Roxadustat Was Met

FibroGen, Inc. (NASDAQ:FGEN) today announced positive topline results from WHITNEY, the Company's Phase 2 clinical study of roxadustat, a first-in-class oral small molecule hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for the treatment of chemotherapy-induced anemia (CIA).

WHITNEY is a Phase 2, open label study investigating the efficacy and safety of roxadustat for treatment of anemia in patients receiving concurrent chemotherapy treatment for non-myeloid malignancies. The primary efficacy endpoint of maximum change in hemoglobin within 16 weeks from baseline without red blood cell transfusion was met.

"Roxadustat is a promising new approach for treating chemotherapy induced anemia, which complicates the treatment of many cancer patients," said Mark D. Eisner, MD, MPH, Chief Medical Officer, FibroGen. "Further studies will be necessary to evaluate whether roxadustat can effectively and safely treat this important type of anemia."

In WHITNEY, ninety-two patients with non-myeloid malignancy (solid tumor) having a hemoglobin level at or below 10 g/dL were enrolled. Patients received a starting roxadustat dose of 2.0 mg/kg or 2.5 mg/kg, three times per week (TIW), during a treatment period of 16 weeks, with an additional 4-week follow-up period. Doses could be titrated every 4 weeks.

Roxadustat was generally well tolerated and there were no substantive differences in treatment-emergent adverse events (TEAEs) between arms with different starting doses.

The full results of the study will be presented at a medical meeting later this year.