02.09.2014 22:55:19
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Tetraphase's Urinary Infection Drug Shows Positive Results In Late-Stage Study
(RTTNews) - Tetraphase Pharmaceuticals Inc. (TTPH) Tuesday said a late-stage study of eravacycline for the treatment of urinary tract infections showed better results compared to standard treatment. Shares of the company gained 7 percent in after-hours trade, following the news.
The top-line results from IGNITE 2 trial, a two-part Phase 3 clinical trial studying the efficacy and safety of intravenous and oral formulations of eravacycline for the treatment of complicated urinary tract infections, showed favorable resutls compared to standard treatment levofloxicin.
The responder outcome, or the primary endpoint for the FDA, for the IV-to-oral 200 mg, IV-to-oral 250 mg and levofloxacin groups were 70.8%, 64.3% and 52.2%, respectively.
Overall, the treatment was generally well tolerated in all three groups with the most common adverse events reported being nausea and emesis.
CEO Guy Macdonald said, "We believe these results are a key step in demonstrating the efficacy and safety of eravacycline as an IV-to-oral treatment option in cUTI and its effectiveness against a broad spectrum of bacterial pathogens, including multidrug resistant Gram-negative bacteria. We look forward to sharing the results of the lead-in portion of IGNITE 2 with the FDA and confirming the dose to carry forward into the pivotal portion of the trial. We remain on track to initiate this stage of the trial in early 4Q '14."
TTPH closed Tuesday's trading at $13.08, down $0.01 or 0.08%, on the Nasdaq. The stock, however, gained $0.92 or 7.03% in after-hours trade.
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