CINCINNATI, Ohio — Akebia Therapeutics is furthest along on an anemia pill that the company hopes will take the place of hormone injections. But there seems to be event more excitement in the business about a second treatment, meant to treat vascular leak.
Vascular leak syndrome is a side-effect in cancer treatments in which blood components leak out of veins and into other systems. But it’s also connected to sepsis, peripheral artery disease and retinopathy, among others. Vascular leak is among the side-effects that limits the dosage of the cancer treatment Interleukin-2.
“These are multibillion dollar markets,” Akebia Chief Financial Officer Ian Howes stated.
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Akebia’s drug, called only AKB-97778, maintains the veins structural integrity to stop vascular leak syndrome. The drug may also help by stopping vascular leak keep some cancerous tumors from spreading, the company hopes.
Much of the additional $10 million Akebia raised in July was meant to speed the development of this drug. Howes said Akebia may continue to add cash in the coming months to further fund this drug’s development.
This drug is years, several clinical trials and regulatory pitfalls away from even being seriously considered for mainstream use. The nascent tests have been promising, though. Akebia’s drug has saved 100 percent of rats and mice who had been dosed with levels of Interleukin 2 that had been fatal.
“Until you get into man you don’t really know for sure,” Howes said.
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The company begins testing next year. It will file an investigational new drug application with the U.S. Food and Drug Administration by the middle of next year and begin a Phase 1 clinical trial, Howes said. If successful, the company would spend all of 2011 on a Phase 2 trial in which the drug would be co-administered to late-stage melanoma patients also using Interleukin-2.
The market for those kinds of patients is about 20,000 annually. But the company hopes success there would earn the drug fast-track approval to treat other diseases, such as sepsis, Howes said.
At the moment, there is little if any development treatment for vascular leak.
“We hope to have a proof of concept roughly two years from now,” he said.
