ZS Pharma bags $55M to take its kidney drug to the FDA

ZS Pharma's lead drug treats hyperkalemia, a potentially fatal disorder often caused by kidney disease.--Courtesy of ZS Pharma

Texas biotech ZS Pharma banked a $55 million D round, cash that should help get its Phase III-tested treatment into the hands of regulators and, eventually, onto the market.

The drug, ZS-9, is designed to treat hyperkalemia, a rise in blood potassium levels often caused by chronic kidney disease or heart failure that can lead to cardiac arrhythmia and sudden death. In top-line results from a 753-patient Phase III trial, the oral treatment met its primary endpoint of significantly lowering serum potassium levels with adverse events similar to placebo, ZS said, charting a promising dose-dependent response for hyperkalemia sufferers.

Now ZS is gearing up for two more studies to confirm the drug's ideal dosing with plans to submit FDA and EMA applications by 2015, the company said, expecting $55 million to carry it through the regulatory process. Whether the biotech will eventually look to partner up remains to be seen, and ZS didn't respond to a request for comment on Thursday.

New investor Novo A/S ($NVO) led ZS's latest round, joining Sofinnova Ventures, Alta Partners, Salem Partners, RiverVest and others. The raise follows a $46 million Series C from 2012, which funded ZS-9's first Phase III study.

Meanwhile, 2008 Fierce 15 honoree and 2013 IPO success story Relypsa ($RLYP) is chasing the same target, working through Phase III on the hyperkalemia-treating patiromer and expecting to submit an NDA in the third quarter of this year. And the market has faith in Relypsa's odds: After pricing its IPO at $11 a share back in November, the company's stock price has soared about 377%.

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