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Akebia begins Phase 2a trial of oral anemia drug

Akebia Therapeutics Inc. has begun a Phase 2a clinical trial of its orally administered anemia drug. The company recently completed a Phase 1b trial of the drug, called AKB-6548, that showed an increase in erythropoietin, immature red blood cells and hemoglobin with “no significant adverse events,” according to a statement from the Cincinnati-area drug developer. […]

Akebia Therapeutics Inc. has begun a Phase 2a clinical trial of its orally administered anemia drug.

The company recently completed a Phase 1b trial of the drug, called AKB-6548, that showed an increase in erythropoietin, immature red blood cells and hemoglobin with “no significant adverse events,” according to a statement from the Cincinnati-area drug developer. Erythropoietin is a  hormone that promotes the growth of red blood cells in bone marrow.

The Phase 2a study is designed to evaluate the safety, tolerability and pharmacokinetics — the rate at which drugs are absorbed, distributed, metablized and eliminated within the body — of a single dose of the drug in chronic kidney disease patients.

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A Deep-dive Into Specialty Pharma

A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.

Akebia is racing against several competitors to fill what it sees as an unmet market need for an oral anemia drug. The company  began its Phase 1b trial in February.

The $10 billion-a-year, worldwide market for chronic anemia drugs is dominated by injectable forms of recombinant erythropoietin, Akebia said. These injections can cost thousands of dollars a year. There are no oral, small-molecule drugs to treat chronic anemia on the market, though some large drugmakers like GlaxoSmithKline and Takeda Pharmaceuticals, as well as Akebia, are working on them.

The Phase 2a trial is expected to be completed in January and will involve up to 28 patients at two U.S. sites, according to the statement.

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.