Akebia Therapeutics' ($AKBA) in-development pill for anemia met its goals in a Phase II study, sending the company's share price soaring as it plots a late-stage trial.
In a trial on 94 dialysis patients with anemia related to chronic kidney disease, Akebia tested whether its oral vadadustat could maintain healthy hemoglobin levels after switching subjects from intravenous recombinant erythropoiesis-stimulating agent therapy, a standard treatment for anemia. After 16 weeks, all three doses of vadadustat held hemoglobin at baseline levels, the Cambridge, MA-based company said, and the drug charted no treatment-related serious adverse events or deaths.
The positive results sent Akebia's share price up more than 80% overnight on Tuesday as investors regained some confidence in the company's lead asset. In October, vadadustat posted mixed results in a trial on anemia patients not on dialysis, marring Akebia's market value and stirring doubts about the drug's future in what is expected to be a crowded space.
But Akebia never publicly wavered on vadadustat's potential to disrupt the standard of care in anemia, and the biotech says it's still on track to launch a Phase III trial on the drug later this year.
"These results further confirm vadadustat as a potential best-in-class anemia treatment for CKD patients, and reinforce our confidence in this product candidate as we advance toward our Phase III program," CEO John Butler said in a statement. "Adding these results to the 12 other clinical studies we have completed, we are confident in the potential for vadadustat to treat anemia in a broad array of patients with CKD."
Meanwhile, Akebia rival FibroGen ($FGEN) has already begun Phase III development for its similar roxadustat, partnered with AstraZeneca ($AZN) and Astellas. And GlaxoSmithKline ($GSK) is working through Phase II with 1278863, an anemia treatment with the same target.
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