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Akebia surges after positive results in Phase 3 studies of kidney disease-related anemia

The studies of vadadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, were conducted by its commercialization collaboration partner in Japan, Mitsubishi Tanabe Pharma
An illustration of kidneys
The kidney-related anemia studies met their primary endpoints, Akebia said

Akebia Therapeutics Inc (NASDAQ:AKBA) surged Tuesday after reporting positive results from a pair of Phase 3 studies on the treatment of anemia related to chronic kidney disease.

The studies of vadadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, were conducted by its commercialization collaboration partner in JapanMitsubishi Tanabe Pharma Corp.

Shares of Akebia rallied 25% to $9.19 in Tuesday’s premarket Nasdaq trading.

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Each study, one in non-dialysis dependent subjects and one in hemodialysis-dependent subjects, met its primary endpoint, according to Akebia. In addition, results from two Phase 3 single-arm studies conducted by Mitsubishi Tanabe, further supported vadadustat’s potential, according to Cambridge, Massachusetts-based Akebia.

Mitsubishi Tanabe expects to submit a new drug application in 2019 in Japan.

“These data provide further confirmation of vadadustat’s potential to meaningfully transform the treatment paradigm for patients with anemia due to chronic kidney disease,” Akebia CEO John P. Butler said in a statement. “These results add to our data set demonstrating the potential for vadadustat to effectively manage hemoglobin levels in both dialysis-dependent and non-dialysis-dependent patients.”

Phase 3 outcomes

A phase 3 randomized, open-label, active-controlled correction and conversion study for non-dialysis dependent subjects met its primary endpoint, with the mean hemoglobin level at week 20 and week 24 at 11.66 grams per deciliter for vadadustat-treated subjects, compared with 11.93 for other subjects. Another Phase 3 study of hemodialysis subjects also met its primary endpoint, with the mean hemoglobin level at week 20 and week 24 at 10.61 grams per deciliter, compared with 10.65 for other subjects.

Anemia is common in patients with chronic kidney disease, and in Japan, an estimated 13 million people are afflicted with advanced stages of chronic kidney disease, according to Akebia.

Vadadustat, if approved for marketing, would provide patients with a once-daily oral treatment option and has the potential to set a new standard of care, the company said.

Contact Dennis Fitzgerald at [email protected]

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