WATERTOWN, Mass., Sept. 3, 2015 (GLOBE NEWSWIRE) -- Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH) today announced that the U.S. Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) and Fast Track designations for the intravenous formulation of TP-271, the Company’s novel, broad spectrum antibiotic candidate which is being developed to combat respiratory disease caused by bacterial biothreats and antibiotic-resistant public health pathogens, including Francisella tularensis, Yersinia pestis and Bacillus anthracis, as well as bacterial pathogens associated with community-acquired bacterial pneumonia.
Tetraphase is developing TP-271 with funding from the National Institutes of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID) which supports preclinical development, manufacturing and phase 1 clinical, safety and pharmacokinetic evaluation of TP-271. In preclinical studies, TP-271 has demonstrated potency against Gram-negative and Gram-positive pathogens associated with respiratory tract infections.
“These important FDA designations provide significant support for the development of new antibiotic treatments for serious and potentially life-threatening respiratory infections, particularly those that are drug resistant,” said Guy Macdonald, Tetraphase’s President and Chief Executive Officer. “Our Investigational New Drug application was recently accepted by the FDA, and we look forward to working with our colleagues at NIAID to advance TP-271 into the clinic.”
Macdonald continued, “TP-271 is Tetraphase’s second drug candidate to receive the QIDP and Fast Track designations which validates the ability of our chemistry platform to generate novel antibiotics targeted against multidrug-resistant bacteria.”
The QIDP and Fast Track designations were granted for the treatment of community-acquired bacterial pneumonia. The QIDP designation makes TP-271 eligible to benefit from certain incentives for the development of new antibiotics provided under the Generating Antibiotic Incentives Now Act (GAIN Act). These incentives include priority review and eligibility for an additional five-year extension of Hatch-Waxman exclusivity. Fast Track designation is awarded to expedite the study and regulatory review of drugs intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.
More About The GAIN Act
Enacted in July 2012, 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.
About Tetraphase Pharmaceuticals, Inc.
Tetraphase is a clinical-stage biopharmaceutical company using its proprietary chemistry technology to create novel antibiotics for serious and life-threatening multidrug-resistant (MDR) bacterial infections, including those caused by many of the MDR Gram-negative bacteria highlighted as urgent public health threats by the CDC. Tetraphase’s lead product candidate, eravacycline, is being developed as a broad-spectrum intravenous and oral antibiotic in the IGNITE program (Investigating Gram-negative Infections Treated with Eravacycline). This program includes two phase 3 clinical trials: IGNITE1 for the indication of complicated intra-abdominal infections (cIAI) and IGNITE2 for the indication of complicated urinary tract infections (cUTI). Tetraphase has created more than 3,000 novel tetracycline analogs using its proprietary technology platform. In addition to eravacycline, Tetraphase’s pipeline includes two preclinical antibiotic candidates, TP-271 and TP-6076. Please visit www.tphase.com for more company information.
Forward-Looking Statements
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 “anticipates,” “believes,” “expects,” “plans,” “will” 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 results obtained in preclinical studies and early or interim clinical trials will be indicative of results obtained in future clinical trials; whether eravacycline or any other clinical candidate will advance through the clinical trial process on a timely basis; whether the results of the Company’s trials will warrant regulatory submission and receive approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; whether, if eravacycline or any other clinical candidate obtains approval, it will be successfully distributed and marketed; and other factors discussed in the “Risk Factors” section of our quarterly report on Form 10-Q, filed with the Securities and Exchange Commission on August 6, 2015. In addition, the forward-looking statements included in this press release represent our views as of September 3, 2015. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so.
CONTACT: Investor Contacts: Tetraphase Pharmaceuticals Teri Dahlman 617-600-7040 tdahlman@tphase.com Argot Partners Susan Kim 212-600-1902 susan@argotpartners.com Media Contact: Sam Brown Inc. Mike Beyer 312-961-2502 mikebeyer@sambrown.com
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