Full steam ahead
Why Akebia thinks investors will back Phase III despite deaths in CKD Phase IIb
Akebia Therapeutics Inc. is moving ahead with plans to begin a Phase III trial of anemia candidate AKB-6548 in the second half of next year, despite investors' swift and negative reaction to deaths reported in a Phase IIb study. The company says the deaths are not a safety signal, and it will have plenty of positive catalysts before it needs to raise money for the next study.
Top-line data from the company's first Phase IIb trial, reported on Monday, Oct. 27, showed AKB-6548 met the primary endpoint of increasing hemoglobin levels vs. placebo in patients with anemia secondary to chronic kidney disease (CKD). But there was a higher proportion of serious adverse events in the treatment arms, including three deaths, one of which was ruled to be possibly related to treatment...