- In an update to investors, Akebia Therapeutics (AKBA -1.6%) announces that it and commercialization partner Mitsubishi Tanabe Pharma have changed the designs of two Japan-based Phase 3 studies, FO2RWARD and TRILO2GY, evaluating vadadustat in patients with anemia associated with dialysis-dependent chronic kidney disease ((DD-CKD)).
- FO2RWARD will now include a broader dialysis population and larger sample size with once-daily and 3x/week dosing. It is designed to inform ESA (erythropoietin stimulating agent)-switching protocols. The study will be initiated next quarter with top-line data expected by year-end/early 2019.
- TRILO2GY will also include a larger sample size and once-daily and 3x/week dosing. It is designed to inform switching from Amgen (NASDAQ:AMGN)'s Epogen (epoetin alfa) and Aranesp (darbepoetin alfa) and Vifor Pharma's Mircera (methoxy PEG-epoetin beta). The study will launch by year-end/early 2019 with top-line results expected in early 2020.
- Akebia's two U.S. Phase 3s, INNO2VATE and PRO2TECT, should hit their enrollment targets by year-end. Top-line data are expected in 2019 with market launch to follow on 2020 assuming positive results and the accrual of the required number of major adverse cardiac events (MACE).
- Previously: Akebia's vadadustat shows positive results in Japan-based anemia study (Jan. 4)
- Now read: Biotech Forum Daily Digest For February 12th
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