Phase 2 Trial of Eravacycline for Complicated Intra-Abdominal Infections
Tetraphase Pharmaceuticals announced positive Phase 2 data on eravacycline at the 52nd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC). The results of the study show that eravacycline was highly active against drug-resistant bacterial pathogens, demonstrating infection cure rates similar to that of ertapenem (the comparator drug used in the trial) for the treatment of cIAI and a strong safety profile (with low rates of gastrointestinal side effects).
In this randomized, double-blind, double-dummy Phase 2 trial of eravacycline, patients with documented complicated intra-abdominal infections were randomized (2:2:1) into one of three arms to receive eravacycline at 1.5mg/kg IV QD intravenously, eravacycline at 1.0mg/kg BID intravenously, or ertapenem at 1g intravenously QD. Investigators obtained baseline intra-abdominal cultures at the time of operation, and treated patients for up to 14 days. Ten to 14 days after end of therapy, patients returned for a test of cure (TOC) visit. The primary efficacy endpoint was clinical outcome at TOC visit in the microbiologically evaluable population.
The trial enrolled 143 patients [75 (52.4%) with complicated appendicitis and 68 (47.6%) with other diagnoses]. Treatment arms were well matched for baseline characteristics. A total of 191 pathogens were isolated from 109 patients in the ME population. Isolates included Escherichia coli (n=86), Klebsiella spp. (n=20), Acinetobacter spp. (n=5) Pseudomonas aeruginosa (n=6), enterococci (n=13), streptococci (n=18), Staphylococcus aureus (n=6) and Bacteroides spp. (n=11). All treatment arms in the trial demonstrated cure rates in the ME population of between 93 and 100%. There were no serious adverse events related to eravacycline. Overall adverse events, including low rates of gastrointestinal side effects, were not significantly different among the randomized groups.
Eravacycline is a potent new antibiotic that is demonstrating efficacy against multidrug-resistant gram-negative pathogens.
For more information visit www.tphase.com.