FibroGen launches mid-stage study of roxadustat in chemo-induced anemia

Dosing is underway in a Phase 2 clinical trial evaluating FibroGen’s (NASDAQ:FGEN) roxadustat in patients with chemotherapy-induced anemia.

The primary endpoint is the maximum change in hemoglobin at week 16. The estimated primary completion date is July 2020.

Roxadustat failed to demonstrate non-inferiority (no worse than) to epoetin alfa (Janssen’s Procrit) in ~4,000 dialysis patients with CKD-related anemia.

Roxadustat is an orally administered small molecule inhibitor of hypoxia-inducible factor (HIF) prolyl hydroxylase. HIF is a protein transcription factor that “turns on” the production of red blood cells (erythropoiesis). Its value proposition is the ability to maintain hemoglobin levels without affecting inflammation and potentially avoiding the need for ongoing intravenous iron repletion therapy as needed with epoetin alfa.

https://seekingalpha.com/news/3501980-fibrogen-launches-mid-stage-study-roxadustat-chemo-induced-anemia