Akebia Therapeutics Inc.'s vadadustat worked as well as Amgen Inc.'s Aranesp in treating anemia among patients with chronic kidney disease, results from two late-stage studies showed.
Both studies evaluated Akebia's medicine in Japanese patients, but in the J01 trial, subjects were not undergoing hemodialysis, while in the J03 trial, patients were undergoing the treatment, which is meant to purify the blood of a person whose kidneys are not working normally.
Anemia is a common disorder that occurs when a deficiency in red blood cells impedes the delivery of oxygen throughout a person's body.
The phase 3 trials showed that vadadustat worked as well as Aranesp in patients when it was evaluated after 20 weeks and 24 weeks. The main goal of the studies was to maintain a mean hemoglobin level similar to Aranesp.
Aranesp is an erythropoiesis-stimulating agent, or ESA, a class of drugs that are currently the standard of care for anemia patients with chronic kidney disease, or CKD, and work by causing the bone marrow to produce red blood cells. Other ESAs in the market include Amgen's Epogen and Johnson & Johnson's Procrit.
Vadadustat is an HIF prolyl hydroxylase inhibitor, which is designed to mimic the body's response to less oxygen at high altitude. At high altitude, the body increases the production of HIF, which leads to higher red blood cell production and improved hemoglobin.
In Japan, an estimated 13 million people are diagnosed with advanced stages of CKD. Anemia is common in patients with CKD and its prevalence increases as CKD progresses. Injectable ESAs are the standard of care, and vadadustat, if approved for marketing, would provide patients with a once-daily oral treatment option.
The studies were conducted by Akebia's Japanese collaboration partner Mitsubishi Tanabe Pharma Corp. Osaka, Japan-based Mitsubishi Tanabe plans to submit a Japanese new drug application for vadadustat in 2019.
The Cambridge, Mass.-based company also reported results from two single arm open-label phase 3 studies, where both patients and researchers knew that vadadustat was being administered.
Akebia Therapeutics' stock price rose by about 21.93% to $8.95 per share in pre-market trading on Nasdaq on March 12.