Eravacycline is a broad-spectrum intravenous and oral antibiotic for the treatment of multidrug-resistant ( MDR ) infections, including those caused by MDR Gram-negative bacteria.
A phase 3 Program called IGNITE ( Investigating Gram-negative Infections Treated with Eravacycline ) is investigating the safety and efficacy of Eravacycline for the treatment of complicated intra-abdominal infections ( cIAI )( IGNITE 1 ), and complicated urinary tract infections ( cUTI )( IGNITE 2 ).

Eravacycline has been designated by the FDA ( Food and Drug Administration ) as a Qualified Infectious Disease Product, or QIDP, for both the complicated intra-abdominal infections and complicated urinary tract infections indications.
The QIDP designation makes Eravacycline eligible for priority review and an additional five years of U.S. market exclusivity, if approved.

Eravacycline is a novel, fully synthetic tetracycline antibiotic.

Eravacycline was selected for development from tetracycline derivatives that were generated on the basis of the following characteristics of the compound that researchers observed in in-vitro studies of the compound: a) potent antibacterial activity against a broad spectrum of susceptible and multi-drug resistant bacteria, including Gram-negative, Gram-positive, atypical and anaerobic bacteria; b) potential to treat the majority of patients as a first-line empiric monotherapy with convenient dosing; and c) potential for intravenous-to-oral transition therapy.

In in-vitro studies, Eravacycline has been highly active against emerging MDR pathogens like Acinetobacter baumannii as well as clinically important species of Enterobacteriaceae, including those isolates that produce ESBLs or that are resistant to the Carbapenem class of antibiotics, and anaerobes.

Based on in-vitro studies we have completed, Eravacycline shares a similar potency profile with carbapenems except that it more broadly covers Gram-positive pathogens like MRSA and enterococci, is active against carbapenem-resistant Gram-negative bacteria and unlike carbapenems like Primaxin and Merrem is not active against Pseudomanas aeruginosa.
Eravacycline has demonstrated strong activity in vitro against Gram-positive pathogens, including both nosocomial and community-acquired Methicillin susceptible or resistant Staphylococcus aureus strains, Vancomycin susceptible or resistant Enterococcus faecium and Enterococcus faecalis, and Penicillin susceptible or resistant strains of Streptococcus pneumoniae.
In in-vitro studies for complicated intra-abdominal infections, Eravacycline consistently exhibited strong activity against enterococci and streptococci.
One of the most frequently isolated anaerobic pathogens in complicated intra-abdominal infections, either as the sole pathogen or often in conjunction with another Gram-negative bacterium, is Bacteroides fragilis. In these studies Eravacycline demonstrated activity against Bacteroides fragilis and a wide range of Gram-positive and Gram-negative anaerobes. ( Xagena )

Source: Tetraphase, 2015

XagenaMedicine2015