“We are highly encouraged by the CHMP’s opinion recommending Xerava for the treatment of cIAI, as it marks an exciting milestone in reaching our goal of bringing this antibiotic to patients in Europe,” said
Mr. Macdonald added, “We believe Xerava is well-positioned to be an empiric antibiotic treatment for cIAI. It also provides physicians an alternative to carbapenems and beta-lactams with beta-lactamase inhibitors. In institutions where Gram-negative resistance is a concern, we feel Xerava offers a clear advantage because it covers many MDR pathogens, which some carbapenems and beta-lactams with beta-lactamase inhibitors do not. We look forward to the continued collaboration with the EMA to complete the regulatory process in Europe.”
The CHMP opinion is based on a comprehensive data package from IGNITE1 and IGNITE4, which were part of the Company’s phase 3 Investigating Gram-negative Infections Treated with Eravacycline (IGNITE) program. In IGNITE1, twice-daily intravenous (IV) Xerava met the primary endpoint, demonstrating non-inferiority in clinical cure versus IV ertapenem in 536 patients using a 10% non-inferiority margin. In IGNITE4, a second phase 3 clinical trial in patients with cIAI, twice-daily IV Xerava met the primary endpoint, demonstrating non-inferiority in clinical cure versus IV meropenem in 500 patients using a 12.5% non-inferiority margin. In both IGNITE1 and IGNITE4, Xerava was well-tolerated and achieved high cure rates in patients with Gram-negative pathogens, including resistant isolates. The Company is also using the results from IGNITE1 and IGNITE4 to support a NDA for Xerava in cIAI with the FDA.
Xerava is a novel, fully-synthetic fluorocycline antibiotic being developed for the treatment of cIAI and other serious infections, including those caused by MDR pathogens that have been highlighted as urgent public health threats by both the
Tetraphase is a biopharmaceutical company using its proprietary chemistry technology to create novel antibiotics for serious and life-threatening bacterial infections, including those caused by many of the MDR bacteria highlighted as urgent public health threats by the WHO and CDC. The Company has created more than 3,000 novel tetracycline compounds using its proprietary technology platform. Tetraphase's pipeline includes three antibiotic clinical candidates: Xerava, TP-271 and TP-6076. Xerava has completed phase 3 clinical testing and is under review for potential approval in cIAI by the
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Source: Tetraphase Pharmaceuticals, Inc.