Akebia says drug shows higher safety issues, shares plunge

(Reuters) - Akebia Therapeutics Inc said there were serious side-effects among patients taking its experimental anemia drug, sending its shares down 66 percent and raising questions about the future of a potential blockbuster. The mid-stage study tested the oral drug, AKB-6548, in patients with anemia related to chronic kidney disease who were not on dialysis. "Of the 49 SAEs (serious adverse events) reported in the active treatment group, one was considered probably related to active treatment and two were considered possibly related, including one death," the company said. The incidence of serious adverse events in the active treatment group was 23.9 percent compared to 15.3 percent for the placebo group, Akebia said on Monday. The company said the drug met its main goal of raising and maintaining hemoglobin levels in some patients. Akebia said it planned to begin late-stage trials of the drug in 2015. UBS analyst Matthew Roden said the drug, if successful, has blockbuster potential. "We expected AKB-6548 to be well-positioned among competitors due to attractive once-daily dosing ...," he wrote in a note to clients. About 30 million people in the United States have chronic kidney disease, with an estimated 1.8 million of these patients suffering from anemia, Akebia said. The company is also testing the drug in chronic kidney disease patients undergoing dialysis and those with idiopathic age-related anemia. Akebia's shares, which listed at $17 on March 20, hit a record-low of $11.85 before regaining some of their losses to trade down 29 percent at $14.00 by midday. More than 1 million shares changed hands by 11:45 a.m. ET, eight times their 10-day moving average. (Reporting by Amrutha Penumudi and Natalie Grover in Bangalore; Editing by Sriraj Kalluvila)