Tetraphase
Pharmaceuticals, Inc., a clinical-stage life science company
developing novel antibiotics effective against antibiotic-resistant
bacteria, presented new, positive Phase 2 clinical data on its lead drug
candidate, eravacycline (TP-434), on September 11, 2012, at the 52nd
Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC)
in San Francisco, CA. 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).
These data support Phase 3 development of eravacycline for the treatment
of serious infections, including those caused by resistant gram-negative
pathogens.
"The rapid rise of multi-drug-resistant bacterial infections (MDR) is a
major global public health concern, especially with regard to MDR
gram-negative infections where currently approved products are
increasingly ineffective and few new therapeutic agents are in clinical
development," said Guy
Macdonald, President and Chief Executive Officer of Tetraphase
Pharmaceuticals. "The outstanding clinical and safety results of
Tetraphase's Phase 2 study of eravacycline support this antibiotic's
potential for the treatment of patients with some of the most
drug-resistant bacterial infections. Eravacycline has the opportunity to
meet this urgent medical need both as an I.V. formulation and
potentially as an oral stepdown therapy for use when a patient is
discharged from the hospital."
In this randomized, double-blind, double-dummy Phase 2 trial of
eravacycline, patients with documented cIAI were randomized (2:2:1) into
one of three arms to receive eravacycline at 1.5 mg/kg IV QD
intravenously, eravacycline at 1.0 mg/kg BID intravenously, or ertapenem
at 1 g 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. Clinical outcomes, microbiological outcomes and
safety parameters were recorded at all visits. The primary efficacy
endpoint was clinical outcome at TOC visit in the microbiologically
evaluable population.