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Positive Phase III Data Reported for Eravacycline in Complicated Intra-Abdominal Infections
Positive results have been reported from a phase III trial of the investigational broad-spectrum antibiotic eravacycline (Tetraphase Pharmaceuticals) for the treatment of complicated intra-abdominal infection (cIAI) compared with ertapenem (Invanz, Merck).
Eravacycline met the study’s primary endpoint of statistical non-inferiority of clinical response at the test-of-cure visit, which took place 25 to 31 days after the initial dose. Secondary analyses were consistent with and supportive of the primary outcome.
No drug-related serious adverse events (AEs) occurred during the trial. The most commonly reported drug-related AEs for eravacycline were gastrointestinal in nature, including nausea (3.3%) and emesis (2.2%).
The spectrum of pathogens in the study was similar to that seen in other pivotal trials in this patient population. The most common gram-negative pathogens included Escherichia coli, Klebsiella pneumonia, Pseudomonas, and Bacteroides.
The IGNITE 1 trial was a randomized, double-blind, double-dummy, global clinical trial designed to assess the efficacy and safety of eravacycline, dosed intravenously 1.0 mg/kg every 12 hours, compared with ertapenem, dosed intravenously 1 g every 24 hours, in the treatment of patients with cIAI. A total of 541 adults were enrolled at 66 centers worldwide.
Eravacycline is being developed as a broad-spectrum intravenous and oral antibiotic in the IGNITE (Investigating Gram-Negative Infections Treated With Eravacycline) program, which consists of two phase III clinical studies: IGNITE 1 for the indication of cIAI; and IGNITE 2 for complicated urinary-tract infections (cUTIs). Eravacycline has been designated by the FDA as a qualified infectious disease product (QIDP) for both indications. This designation, which is assigned to qualifying new antibiotic product candidates, makes eravacycline eligible to benefit from certain development and commercialization incentives, including priority review and eligibility for both fast-track status and an additional 5 years of U.S. market exclusivity.
Source: TetraPhase Pharmaceuticals; December 17, 2014.