TetraPhase Drops After the FDA Requests More Data for Eravacycline NDA Submission
– Additional phase 3 clinical trial in cIAI planned to support NDA filing –
–Phase 3 clinical trial in cUTI planned for future supplemental NDA –
– Company to host conference call at 4:30 p.m. ET today –
WATERTOWN, Mass., May 12, 2016 (GLOBE NEWSWIRE) -- Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a clinical stage biopharmaceutical company developing novel antibiotics to treat life-threatening multidrug-resistant (MDR) infections, today announced that it has received guidance from the U.S. Food and Drug Administration (FDA) regarding the regulatory path of the Company’s lead candidate, eravacycline, an antibiotic with potent activity against drug-resistant bacteria, including MDR pathogens highlighted as urgent public health threats by the CDC. In its written response, the FDA advised Tetraphase that data from one additional positive phase 3 clinical trial will be required to support a New Drug Application (NDA) submission for IV eravacycline.
Based on the FDA’s response, Tetraphase plans to conduct a pivotal phase 3 clinical trial to evaluate the efficacy and safety of twice-daily IV eravacycline in patients with complicated intra-abdominal infections (cIAI). The Company expects to provide details regarding the cIAI study design once the protocol is finalized and is anticipating initiation of this cIAI study to take place early in the fourth quarter of 2016. Top-line results from this cIAI study could be available as early as the fourth quarter of 2017. Assuming a positive outcome, data from this study will be used to support the NDA for IV eravacycline as a treatment for patients with cIAI.
In addition, Tetraphase also plans to conduct a phase 3 clinical trial evaluating the efficacy and safety of once-daily IV eravacycline in patients with complicated urinary tract infections (cUTI). The Company expects to provide details regarding this cUTI study design once the protocol is finalized. Assuming a positive outcome, data from this study will form the basis of a supplemental NDA (sNDA) for IV eravacycline to support treatment in the additional indication of cUTI.
“With a written response from FDA now in hand, we have a confirmed path forward which requires one additional successful phase 3 trial to support an NDA filing for eravacycline,” said Guy Macdonald, Tetraphase’s President and Chief Executive Officer. “We have determined that a trial evaluating IV eravacycline in cIAI provides for the most rapid path to approval, and most importantly, the most rapid path to making eravacycline available to patients. We expect that our existing cash resources are sufficient to fund operations through the data readout for this planned cIAI clinical trial. In parallel, we plan to conduct another phase 3 trial evaluating IV eravacycline in cUTI, and assuming a successful outcome, will use those results to support an sNDA.”
Mr. Macdonald continued, “While the time to an NDA filing for eravacycline is longer than we had hoped, our successful phase 3 IGNITE1 study for IV eravacycline in cIAI as well as the promising IV-only efficacy data analysis from the IGNITE2 study in cUTI give us confidence that eravacycline has the potential to become an important option for patients with drug-resistant infections. Our near-term focus for IV eravacycline will be on initiating the additional phase 3 clinical trials in both cIAI and cUTI. Work for both trials is already underway and we look forward to communicating study design details once the clinical trial protocols are finalized.”
In addition to the clinical program for IV eravacycline, Tetraphase recently initiated clinical testing designed to advance the oral development program for eravacycline.
Conference Call Information
Tetraphase will host a conference call today at 4:30 pm Eastern Time. The call can be accessed by dialing (844) 831-4023 (U.S. and Canada) or (731) 256-5215 (international) and entering passcode: 11716230. To access the live audio webcast, or the subsequent archived recording, visit the "Investor Relations — Events & Presentations" section of the Tetraphase website at www.tphase.com. The webcast will be recorded and available for replay on the Tetraphase website for 30 days following the call.
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 bacterial infections, including those caused by many of the multidrug-resistant (MDR) 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 its late-stage broad-spectrum antibiotic, eravacycline, as well as two additional 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 will advance through the clinical trial process; whether the results of the Company's development efforts will warrant regulatory submission and whether any such submissions will receive approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; whether, if eravacycline obtains approval, it will be successfully distributed and marketed; whether our cash resources will be sufficient to fund our continuing operations for the period anticipated; 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 May 4, 2016. In addition, the forward-looking statements included in this press release represent our views as of May 12, 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.
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