Akebia’s prospects dim after safety readout in non-dialysis CKD patients

The failure of Akebia’s vadadustat on a Phase III safety endpoint in a subset of chronic kidney disease patients won’t stop the company from submitting the molecule to regulators. But the readout surprised investors and destroyed more than $1 billion in the company’s market cap, and it could widen a commercial avenue for a rival drug from Fibrogen.

Akebia Therapeutics Inc. (NASDAQ:AKBA) said Thursday that vadadustat missed the primary safety endpoint in the Phase III PRO2TECT program, which evaluated the oral HIF-PH inhibitor to treat anemia in non-dialysis-dependent CKD patients. Vadadustat did not show non-inferiority to erythropoietin-stimulating agent Aranesp darbepoetin alfa as measured by time to first occurrence of major adverse cardiovascular events, or MACE (non-inferiority margin=1.25; HR=1.17; 95% CI: 1.01, 1.36)...