WATERTOWN, Mass., Jan. 19, 2016 (GLOBE NEWSWIRE) — Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH) today announced the initiation of patient dosing in a phase 1 clinical trial for intravenous (IV) TP-271, a 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.
“The initiation of this first-in-man phase 1 study for TP-271 demonstrates continued progress with the Company’s pipeline of novel antibiotic candidates,” said Patrick Horn, Chief Medical Officer of Tetraphase. “With preclinical data supporting its activity against a broad-spectrum of bacterial pathogens, we look forward to evaluating TP-271 in the clinic.”
The trial is a randomized, double-blind, placebo-controlled, single-ascending-dose (SAD), single-center study in up to 56 healthy volunteers. This is the first study in a phase 1 clinical program which is also expected to include a multiple-ascending dose (MAD) study for IV TP-271 followed by SAD and MAD studies for oral TP-271. In September 2015, TP-271 received Qualified Infectious Disease Product and Fast Track designations from the FDA for the treatment of community-acquired bacterial pneumonia.
Tetraphase is developing TP-271 with funding from the National Institutes of Health’s National Institute of Allergy and Infectious Diseases, 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.
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 has created more than 3,000 novel tetracycline analogs using its proprietary technology platform. Tetraphase’s pipeline includes three antibiotic candidates: eravacycline, its late-stage clinical candidate, 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 TP-271 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 any 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 November 2, 2015. In addition, the forward-looking statements included in this press release represent our views as of January 19, 2016. 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
