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news.The US Food & Drug Administration (FDA) has granted fast track designations for both the intravenous (IV) and oral formulations of Tetraphase Pharmaceuticals' lead antibiotic candidate, eravacycline.
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Currently, the company is evaluating the safety and efficacy of eravacycline in a Phase III clinical program, which includes two trials.
The IGNITE 1 trial is assessing the IV formulation of eravacycline for the treatment of complicated intra-abdominal infections (cIAI), while IGNITE 2 is evaluating eravacycline IV-to-oral step-down therapy for the treatment of complicated urinary tract infections (cUTI).
Eravacycline became eligible for Fast Track status as a result of being designated a Qualified Infectious Disease Product (QIDP), which makes the product eligible for priority review and an additional five years of market exclusivity in the US, if approved.
The incentives are part of the Generating Antibiotic Incentives Now Act (GAIN Act), which was enacted in July 2012 as part of the FDA Safety and Innovation Act (FDASIA) and was part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V).
Tetraphase president and CEO Guy Macdonald said the company is happy that eravacycline has received Fast Track designation for both formulations and for both therapeutic indications being pursued.
"There is a serious and growing public health threat as a result of the rise in increasingly difficult-to-treat bacterial infections, particularly those caused by multidrug-resistant Gram-negative bacteria," Macdonald said.
"With eravacycline and our pipeline of novel antibiotic candidates, we are attempting to directly address this threat. We look forward to working closely with the FDA as we continue to advance eravacycline through Phase 3 development and through the preparation and submission of our NDA filing, which is targeted for the end of 2015."
The randomized, multi-center, double-blind, double-dummy IGNITE 1 Phase III trial is designed to evaluate the efficacy and safety of eravacycline, dosed intravenously 1mg/kg every 12 hours, compared with ertapenem, dosed intravenously 1g every 24 hours, in the treatment of cIAI.
About 536 adult patients are expected to be enrolled in the trial to be carried out at around 100 centers worldwide.
Primary endpoint of IGNITE 1 is clinical response at the test-of-cure visit in the microbiological intent-to-treat (micro-ITT) patient population.
IGNITE 2 is a two-part, randomized, multi-center, double-blind, Phase III trial designed to evaluate the efficacy and safety of eravacycline compared with levofloxacin in the treatment of cUTI at about 150 clinical trial sites worldwide.
The two-part trial features a lead-in portion, in which about 120 patients, randomized 1:1:1, will receive eravacycline in one of two IV-to-oral step down dosing cohorts or levofloxacin.