Tetraphase Pharmaceuticals Inc. is closer to filing for FDA and EMA approval of eravacycline the drug could become only the second tetracycline antibiotic cleared in more than 30 years after reporting positive top-line data from the phase III IGNITE 1 study in complicated intra-abdominal infections (cIAIs) testing eravacycline against ertapenem.
Eravacycline met the primary endpoint of statistical noninferiority of clinical response at the test-of-cure (TOC) visit, according to guidances set by both U.S. and European regulators. Should data from the IGNITE 2 study in complicated urinary tract infections (cUTIs) bear similar results, Watertown, Mass.-based Tetraphase anticipates an FDA new drug application submission by the end of 2015.
The news, which came after markets closed Wednesday, sent shares of Tetraphase (NASDAQ:TTPH) up 19.8 percent in after-hours trading. The stock closed Thursday at $38, up $4.81.