Akebia soars as its anemia pill stacks up to intravenous therapy in Phase II

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.

- read the statement

Suggested Articles

Fifteen of the 22 patients in a gene therapy trial no longer needed transfusions, while the remainder needed fewer transfusions.

Argos Therapeutics is ending its kidney cancer trial and mulling options, including a merger or sale, to stay alive.

CNS Pharma says berubicin is the first anthracycline drug to cross the blood-brain barrier and could transform treatment of the highly invasive brain tumor.