- Eravacycline designated as a QIDP for complicated intra-abdominal infection (cIAI) and complicated urinary tract infection (cUTI) indications -
Eravacycline is being developed as a broad-spectrum IV and oral antibiotic for use as a first-line empiric monotherapy for the treatment of multi-drug resistant infections, including multi-drug resistant Gram-negative infections. Tetraphase is planning to advance eravacycline into Phase 3 clinical studies in cIAI and cUTI in the second half of this year.
"We are delighted that our lead antibiotic product candidate,
eravacycline, has received QIDP designation under the GAIN Act for both
cIAI and cUTI indications. We believe it is the first product candidate
to receive this designation in cIAI," said
About The GAIN Act
The GAIN Act, Title VIII (Sections 801 through 806) of the FDA Safety and Innovation Act, seeks to provide pharmaceutical and biotechnology companies with incentives to encourage the development of new drugs to treat, prevent, detect and diagnose antibiotic-resistant infections. Qualifying pathogens are defined by the GAIN Act to include multi-drug resistant Gram-negative bacteria, including Pseudomonas, Acinetobacter, Klebsiella, and Escherichia coli species; resistant Gram-positive pathogens, including methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Staphylococcus aureus and vancomycin-resistant Enterococcus; multi-drug resistant tuberculosis; and Clostridium difficile. It extends the length of time an approved drug is free from competition and clarifies the regulatory pathway for new antibiotics.
Tetraphase is a clinical-stage biopharmaceutical company using its proprietary chemistry technology to create novel antibiotics for serious and life-threatening multi-drug resistant infections. Tetraphase's lead product candidate, eravacycline, is a fully synthetic tetracycline derivative being developed as a broad-spectrum intravenous and oral antibiotic for use as a first-line empiric monotherapy for the treatment of multi-drug resistant infections, including multi-drug resistant Gram-negative infections.
Any statements in this press release about our future expectations,
plans and prospects, including statements regarding our strategy, future
operations, prospects, plans and objectives, and other statements
containing the words "believes," "anticipates," "plans," "expects," and
similar expressions, constitute forward-looking statements within the
meaning of The Private Securities Litigation Reform Act of 1995. Actual
results may differ materially from those indicated by such
forward-looking statements as a result of various important factors,
including: whether eravacycline will benefit from the QIDP designation;
whether eravacycline will advance through the clinical trial process on
a timely basis; whether the results of the clinical trials of
eravacycline will warrant the submission of applications for marketing
approval, and if so, whether eravacycline will receive approval from the
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