Cincinnati's Akebia starts Phase 1b clinical trial for anemia drug

Small molecule discovery and development company Akebia Therapeutics Inc. has started a second Phase 1 clinical trial of its anemia drug--another baton hand-off in a race with big drug companies to get to market first with a safer, more effective, less expensive oral treatment.

CINCINNATI, Ohio — Small molecule discovery and development company Akebia Therapeutics Inc. has started a second Phase 1 clinical trial of its anemia drug–another baton hand-off in a race with big drug companies to get to market first with a safer, more effective, less expensive oral treatment.

In January, Akebia said it completed its first Phase 1 trial for the drug, known as AKB-6548, showing a single dose successfully and safely produced erythropoietin–the hormone that promotes the growth of red blood cells in bone marrow–in healthy human subjects.

“We are pleased to be rapidly moving AKB-6548 into Phase 1b studies following the successful completion of the Phase 1a trial,” said Joseph Gardner, president and chief executive officer of Akebia, in a written statement.

During the Phase 1b trial, three doses of AKB-6548 will be administered to about 33 healthy volunteers at Cincinnati contract research organization Medpace Inc. over a 10-day period to evaluate the drug’s safety, tolerability and movement through the body. Akebia also plans to measure erythropoietin and other biomarkers during the trial, which is expected to conclude by mid-year.

“In this next study, we will continue to monitor the safety profile of AKB-6548, as well as erythropoietin and other biomarkers, in a multi-dose setting,” Gardner said. “We are excited about the potential of this compound and that early results have supported our goal of providing patients with a product that offers unique advantages over current approaches to address anemia, including simple oral dosing and an improved safety profile.”

AKB-6548 inhibits enzymes that regulate “hypoxia-inducible factors” in the body. These factors respond to a decrease of oxygen, or hypoxia, in cells. Regulating these factors could allow the body to better respond to reduced oxygen, injury and infection, according to Akebia.

Initially, the company’s drug is being developed to help fight chronic anemia in kidney failure patients. But eventually, it could also help heal bone fractures, wounds and other conditions, the company said.

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, though some large drug makers like GlaxoSmithKline and Takeda Pharmaceuticals, as well as Akebia, are working on them.

The Cincinnati company was started three years ago when Procter & Gamble began dismantling its pharmaceuticals division. Gardner, a former Procter & Gamble executive, teamed with Cincinnati venture capital firm Triathlon Medical Ventures to buy two molecules–the anemia treatment and a therapy for preventing some heart-related side effects during cancer treatment.

Akebia has received about $22 million from investors, so far, Ian Howes, Akebia’s chief financial officer and vice president of corporate development, said. The company could take another $15 million in investments this year, mostly from existing investors, though it’s also looking to add one or two new investors.

Several investor groups are looking at the investment opportunity, Howes said.

Akebia also is in early talks with some large U.S., European and Japanese pharmaceutical firms that are interested in partnering with it on a licensing deal, Howes said. The deal could happen as soon as the second half of the year.

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