Tetraphase Pharmaceuticals Inc. said its investigational antibacterial drug eravacycline met the main goals of two late-stage trials in patients with complicated intra-abdominal infections.
Complicated intra-abdominal infections, or cIAI, are conditions in which an infection extends beyond the source organ into the peritoneal space — the space between the two membranes separating the organs in the abdominal cavity from the abdominal wall — due to perforation or other damage to the gastrointestinal tract.
Based on the pooled data from the two phase 3 trials, known as Ignite1 and Ignite4, eravacycline showed high cure rates in patients infected with gram-negative and gram-positive pathogens, including resistant isolates.
Gram-negative bacteria are resistant to multiple drugs and cause infections such as pneumonia, bloodstream infections, wound or surgical site infections and meningitis. Meanwhile, Gram-positive bacteria are more receptive to antibiotics and cause staph infection, streptococcal pharyngitis, diphtheria and anthrax.
In the patient group with cIAI caused by the gram-negative bacteria Enterobacteriaceae, the overall favorable clinical and microbiological response rates for both trials were at 88.2% and 86.3%, respectively. Furthermore, for the group of patients with cIAI caused by gram-negative bacteria A. baumannii, overall favorable clinical and microbiological response rate was 100%.
The U.S. Food and Drug Administration and European Medicines Agency are evaluating the drug for treating cIAI.
Watertown, Mass.-based Tetraphase presented the data at the American Society for Microbiology Microbe 2018 meeting in Atlanta.
