FMS - Cara Therapeutics Reports Success for Korsuva in Pivotal Trial
Shares of clinical-stage biotech Cara Therapeutics (NASDAQ: CARA) rose 4% Tuesday after the company reported successful results from a phase 3 trial of its lead drug Korsuva for pruritis, or severe itching, in hemodialysis patients. Based on the results, Cara and its partner, Fresenius Medical Care (NYSE: FMS) plan to submit a new drug application to the Food and Drug Administration and a marketing authorization approval to the European Medicines Agency in the second half of the year.
The KALM-2 study tested Korsuva injections in 473 kidney disease patients undergoing hemodialysis and who suffered from moderate to severe pruritis. The trial enrolled patients in the U.S. and overseas and was similar to the company's KALM-1 trial, which had been limited to U.S. patients and which concluded successfully last spring. Korsuva met its primary endpoint in KALM-2, with 54% of the subjects reporting an improvement in an itch score after 12 weeks, compared with 42% of the placebo group.
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