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Akebia gets positive results from latest oral anemia drug trial

Akebia Therapeutics Inc. has successfully completed a Phase 2a trial of its orally administered anti-anemia drug for kidney disease patients.

Akebia Therapeutics Inc. has successfully completed a Phase 2a trial of its orally administered anti-anemia drug for kidney disease patients.

Patients who received a single oral dose of the drug, AKB-6548, experienced significantly increased levels of erythropoietin (EPO) for up to 12 hours, according to a statement from the Cincinnati-area drug developer. EPO is a hormone that promotes the growth of red blood cells in bone marrow.

After 24 hours, patients’ EPO levels had declined to baseline levels, which supports the potential for once-daily dosing. The compound was found to be safe, with no serious adverse events, according to the statement.

“All the data is positive, and every card we turn over looks good so far,” said Ian Howes, Akebia’s chief financial officer.

The recently completed Phase 2a study involved patients who received just one dose of the drug. The company’s next step is to conduct another Phase 2a trial in which patients are dosed for 28 days. That likely will be followed by a Phase 2b trial in which patients are dosed for 90 days, Howes said.

The company could file a New Drug Application with the U.S. Food and Drug Administration by the end of 2014, Howes said.

Akebia is racing against several competitors to fill what it sees as an unmet market need for an oral anemia drug. The $10 billion-a-year, worldwide market for chronic anemia drugs is dominated by injectable forms of recombinant erythropoietin, which can cost thousands of dollars a year.

Akebia announced in July that it was initiating the single-dose Phase 2a study of AKB-6548. The trial included 22 chronic kidney disease patients.

Akebia was started three years ago when Procter & Gamble began dismantling its pharmaceuticals division. It raised $28 million during a Series A round. Investors include Novartis Bioventures Ltd., Venture Investors LLC, Triathlon Medical Ventures, Kearny Venture Partners, Athenian Venture Partners and Sigvion Capital.

Despite raising the hefty amount, the company always is on the lookout for more capital or partnership opportunities with pharmaceutical firms to help defray the costs of expensive clinical trials, Howes said.