Akebia Therapeutics has closed a $22 million series B round of investment that will take the company through a pair of phase 2b trials of its oral anemia drug.
The funding is an important milestone for the Cincinnati-based pharmaceutical company as it pushes forward with development of AKB-6548, which is designed to promote levels of erythropoietin (EPO) for up to 12 hours in kidney disease patients. EPO is a hormone that promotes the growth of red blood cells in bone marrow.
The funding will also allow the company to start clinical trials of a second drug candidate, AKB-9778, a treatment for vascular leak, a condition in which blood leaks from the veins into other tissues in the body. Akebia plans to file an Investigational New Drug Application (IND) with the U.S. Food and Drug Administration this summer, CFO Ian Howes said. An approved IND would allow the company to begin testing the drug on humans.
The Series B round was led by Novartis Venture Fund and Venture Investors. Existing investors Triathlon Medical Ventures, Kearny Venture Partners, Athenian Venture Partners and Sigvion Capital, plus new investor AgeChem Venture Fund, also participated.
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 EPO, which can cost thousands of dollars a year.
The company says its drug is potentially safer and cheaper than traditional anemia treatments.
Akebia is looking to start the first 2b trial, which will run for 42 days and enroll 100 patients, in June. A second, 90-day phase 2b trial could begin later this year.
The company is hoping to file a New Drug Application with the U.S. Food and Drug Administration for the anemia drug in 2015, Howes said.
But Akebia will likely need to find a co-development partner or sell itself or its technology before it gets to that stage, Howes said.
“Akebia can’t do phase 3 trials on its own,” Howes said. “We either have to find a partner before then or do a strategic deal … such as a company buying Akebia or buying the drug.”