FDA Fast Tracks Eravacycline for cIAI and cUTI
Tetraphase Pharmaceuticals announced that the FDA granted Fast Track status to intravenous (IV) and oral formulations of eravacycline for the treatment of complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI).
The IGNITE 1 randomized, multi-center, double-blind, double-dummy, non-inferiority (10% margin), global Phase 3 trial is designed to assess the efficacy and safety of eravacycline 1mg/kg IV every 12 hours, compared with ertapenem 1g IV every 24 hours, in the treatment of cIAI (n=536). The primary endpoint is clinical response at the test-of-cure visit in the microbiological intent-to-treat (micro-ITT) patient population.
The IGNITE 2 is a two part, randomized, multi-center, double-blind, noninferiority trial (10% margin) Phase 3 trial designed to assess the efficacy and safety of eravacycline compared with levofloxacin in the treatment of cUTI. The study will be conducted in two portions with an interim analysis after the first portion to determine the dosage of eravacycline used during the second portion of the trial. The initial section will enroll approximately 120 patients randomized 1:1:1 to eravacycine in one of two IV-to-oral step down dosing cohorts (1.5mg/kg IV every 24 hours followed by 200mg or 250mg orally every 12 hours) or (750mg IV every 24 hours followed by 750mg orally every 24 hours). The second half of the study opens enrollment to an additional 720 patients randomized 1:1 to the selected dose regimen of eravacycline or levofloxacin, with clinical and microbiological response measured approximately seven days after treatment completion.
Eravacycline was previously designated by the FDA as a Qualified Infectious Disease Product (QDIP) for cIAI and cUTI.
For more information call (617) 715-3600 or visit TPhase.com.