We are developing our lead product candidate, eravacycline, as a broad-spectrum intravenous and oral antibiotic for the treatment of serious bacterial infections, including those caused by multidrug-resistant (MDR) Gram-negative bacteria. Eravacycline is in a phase 3 program called IGNITE (Investigating Gram-negative Infections Treated with Eravacycline) for the treatment of complicated intra-abdominal infections (cIAI)(IGNITE 1), and complicated urinary tract infections (cUTI)(IGNITE 2). In December 2014, we reported that eravacycline met the primary efficacy endpoint in IGNITE1 and demonstrated a favorable safety and tolerability profile in the study. In September 2015, we announced that eravacycline did not meet the primary efficacy endpoint in IGNITE2. We are further analyzing the IGNITE2 data and plan to provide an update after we discuss our plans for a path forward with the regulatory agencies.
Eravacycline is a novel, fully synthetic tetracycline antibiotic with potent antibacterial activity against a broad spectrum of susceptible and multidrug-resistant bacteria, including Gram-negative, Gram-positive, atypical and anaerobic bacteria; and potential to treat the majority of patients as a first-line empiric monotherapy with convenient once-or twice-daily dosing. In in vitro studies, eravacycline demonstrated potent antibacterial activity against emerging MDR pathogens like Acinetobacter baumannii as well as clinically important species of Enterobacteriaceae, including ESBL-producing Klebsiella pneumoniae or those that are resistant to the carbapenem class of antibiotics.
Eravacycline has been designated by the FDA as a Qualified Infectious Disease Product, or QIDP, for both the cIAI and cUTI indications. The QIDP designation makes eravacycline eligible for priority review and an additional five years of U.S. market exclusivity, if approved. The FDA also granted Fast Track designations for both the cIAI and cUTI indications and the IV and oral formulations of eravacycline. Fast Track designation is awarded to expedite the study and regulatory review of drugs intended to treat serious or life-threatening conditions that demonstrate the potential to address unmet medical needs.
Additionally, in February 2012, Tetraphase announced a contract award from the Biomedical Advanced Research and Development Authority (BARDA) worth up to $67 million for the development of eravacycline, from which Tetraphase may receive up to approximately $40 million in funding. The contract includes preclinical efficacy and toxicology studies; clinical studies; manufacturing activities; and associated regulatory activities to position the broad-spectrum antibiotic eravacycline as a potential empiric countermeasure for the treatment of inhalational disease caused by Bacillus anthracis, Francisella tularensis, and Yersinia pestis. The funding under the BARDA Contract is also being used for certain activities in the development of eravacycline to treat certain infections caused by life-threatening multidrug-resistant bacteria.