Tetraphase's New Antibiotic Succeeds In Phase 3 Study
By C. Rajan, contributing writer
Antibiotic maker Tetraphase has announced positive top-line results from the Phase 3 clinical trial of its novel antibiotic, eravacycline, for the treatment of complicated intra-abdominal infections (cIAI). The study (IGNITE 1) showed that eravacycline is as effective as Merck’s antibiotic, ertapenem.
The global Phase 3 IGNITE 1 clinical trial assessed the safety and efficacy of the IV formulation of eravacycline, compared with ertapenem, in the treatment of cIAI in 541 adult patients. The drug met the primary endpoints set by the U.S. FDA and the European Medicines Agency (EMA).
In the study, Massachusetts based Tetraphase evaluated its lead antibiotic candidate against the most common Gram-negative pathogens including, Escherichia coli, Klebsiella pneumonia, Pseudomonas and Bacteroides. Most Gram-negative bacteria are antibiotic-resistant “superbugs,” which pose an increasingly serious global health problem.
Tetraphase intends to present the data from the trial at scientific meetings next year, and hopes to file for regulatory approval for eravacycline by the end of next year.
Eravacycline is being developed as a broad-spectrum antibiotic monotherapy in both IV and oral formulations for the treatment of multi-drug resistant infections, including multi-drug resistant Gram-negative infections.
Tetraphase is also evaluating eravacycline in a second ongoing Phase 3 trial (IGNITE 2) in 720 patients with complicated urinary tract infections (cUTI), in comparison with Johnson & Johnson's levofloxacin. The results of this study are expected in mid-2015.
Eravacycline received the FDA’s Qualified Infectious Disease Product (QIDP) designation in 2013 for both the cIAI and cUTI indications. The drug was also awarded Fast Track designation in April this year.
"The positive results from IGNITE 1 underscore that treatment with eravacycline could help a significant number of cIAI patients achieve a clinical cure for their difficult-to-treat Gram-negative infections," said Guy Macdonald, president and CEO of Tetraphase.
"The success of this trial is an important milestone for the eravacycline pivotal program. These results, along with those from our ongoing Phase 3 IGNITE 2 trial in complicated urinary tract infections (cUTI), which are expected in mid-2015, would form the basis of regulatory submissions seeking approval for eravacycline in both indications. We continue to target a New Drug Application submission to the FDA by the end of 2015."
If approved, eravacycline will be up against a several new antibiotics designed to fight drug-resistant bacteria, including Cubist’s Zerbaxa, which just received FDA approval. Industry analysts predict that once approved, eravacycline would bring in over $1 billion in sales, as reported by Reuters.