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Monday, October 8, 2018

Tetraphase Presents Positive Data from Phase 3 Anti-infective Trials


XERAVA Demonstrated Efficacy in Treating Secondary Bacteremia in Patients with Complicated Intra-Abdominal Infections in Post-Hoc Analysis of Phase 3 Clinical Trials
TP-6076 Demonstrated Favorable Pharmacokinetic and Safety Profile in Phase 1 Trial, Supporting Advancement into a Bronchopulmonary Disposition Study
Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a biopharmaceutical company focused on developing and commercializing novel antibiotics to treat life-threatening multidrug-resistant (MDR) infections, announced data from a pooled analysis of two Phase 3 studies of XERAVA in complicated intra-abdominal infection (cIAI) and a Phase 1 multiple-ascending dose study for its pipeline candidate TP-6076. These data were presented at the Infectious Disease Society of America’s (IDSA) Infectious Disease Week (IDWeek) 2018, held October 3-7 in San Francisco.
“The data presented at IDWeek demonstrate high clinical cure rates and microbiological eradication with XERAVA among patients with cIAI and concurrent bacteremia,” said Guy Macdonald, President and Chief Executive Officer of Tetraphase. “These data confirm the efficacy of XERAVA in a subgroup of cIAI patients who may be at higher risk for poor outcomes, and this new analysis comes at an exciting time as we make final preparations for the commercial launch of XERAVA in the coming weeks.”
Mr. Macdonald added, “We are also encouraged by the positive safety, tolerability and pharmacokinetic data from the multiple-ascending dose Phase 1 study evaluating a seven-day dosing regimen for intravenous (IV) TP-6076. We plan to advance TP-6076 to a bronchopulmonary disposition study beginning in the first quarter of 2019 to confirm appropriate therapeutic levels of TP-6076 in the lungs to treat infections caused by Acinetobacter baumannii and other MDR pathogens. In previously completed in vitrotesting, TP-6076 MIC90 values were as much as 64-fold lower than those for tigecycline against MDR Gram-negative pathogens, including Acinetobacter baumannii, suggesting that TP-6076 could be a potent treatment for these difficult-to-treat bacteria. We are enthusiastic about the potential for TP-6076 and the future of this program.”

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