– Phase 3 IGNITE4 Results in Complicated Intra-Abdominal Infection Recognized as a ‘Best Rated Abstract’ –
– Other Key Eravacycline and TP-6076 Data to Also be Highlighted –
WATERTOWN, Mass., April 12, 2018 (GLOBE NEWSWIRE) -- Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a biopharmaceutical company focused on developing and commercializing novel antibiotics to treat life-threatening multidrug-resistant (MDR) infections, today announced six data presentations at the 28th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), taking place April 21-24 in Madrid, Spain at the IFEMA – Feria de Madrid. Presentations will include information about the Company’s lead drug candidate, eravacycline, which is in development for the treatment of complicated intra-abdominal infections (cIAI), as well as data for TP-6076, the lead candidate under its second-generation program to target MDR Gram-negative bacteria.
“We are pleased to present data from the IGNITE4 study, which garnered a ‘Best Rated Abstract’ designation at this year’s ECCMID Congress,” said Guy Macdonald, President and Chief Executive Officer of Tetraphase Pharmaceuticals. “In addition, we will share findings from a large-scale surveillance study conducted by the International Health Management Associates in Europe, in which eravacycline demonstrated potent in vitro activity against more than 1,550 multidrug-resistant isolates of clinically significant Gram-negative and Gram-positive organisms collected globally. We believe these data further support the clinical profile of eravacycline in treating serious and life-threatening infections and look forward to the Prescription Drug User Fee Act (PDUFA) goal date of August 28, 2018 for eravacycline.”
Mr. Macdonald adds, “Further, we are encouraged by data demonstrating the in vitro activity of TP-6076. In a study of more than 100 isolates from hospitals in Greece, TP-6076 exhibited greater antimicrobial activity against carbapenem-resistant Acinetobacter baumannii than comparator antibiotics, thereby supporting our commitment to developing this pipeline asset for MDR Gram-negative infections.”
Larry Tsai, M.D., Chief Medical Officer of Tetraphase, stated “I’m pleased to be presenting IGNITE4 data which demonstrate high clinical cure rates in patients with cIAI comparable to meropenem. These data are instrumental in our belief that eravacycline offers a clear advantage to carbapenems in cases where Gram-negative resistance is a concern. We look forward to sharing these important data with the medical community at ECCMID this year.”
The details for the data presentations at ECCMID are as follows:
Eravacycline oral presentation – A ‘Best Rated Abstract’
Presentation title: Results of IGNITE4: a phase-3 study to evaluate the efficacy and safety of eravacycline versus meropenem in complicated intra-abdominal infections
Date and time: Sunday, April 22 from 11:30a.m. – 12:00p.m. CEST
Location: Hall Q
Presentation number: #O0421
Speaker: Larry Tsai, M.D.
Session information: Snapshot on pre-registration clinical trials
Eravacycline poster presentations
Poster Title: In vitro activity of eravacycline and comparators against resistant Gram-negative isolates collected in 2016 from patients in Europe
Date and time: Saturday, April 21 from 3:30 – 4:30 p.m. CEST
Location: Paper Poster Arena
Poster number: #P0099
Session information: Activity of new or re-purposed non-beta lactam drugs against Gram-negatives
Poster title: Eravacycline in vitro activity against European clinical isolates obtained in 2016 from urinary and gastrointestinal sources, including drug resistant pathogens
Date and time: Saturday, April 21 from 3:30 – 4:30 p.m. CEST
Location: Paper Poster Arena
Poster number: #P0100
Session information: Activity of new or re-purposed non-beta lactam drugs against Gram-negatives
Poster Title: Global surveillance of in vitro activity of eravacycline and comparators against Enterobacteriaceae, Stenotrophomonas maltophilia, Staphylococcus aureus and Enterococcus spp. collected during 2016
Date and time: Saturday, April 21 from 3:30 – 4:30 p.m. CEST
Location: Paper Poster Arena
Poster number: #P0101
Session information: Activity of new or re-purposed non-beta lactam drugs against Gram-negatives
Poster title: Eravacycline is active against bacterial isolates carrying emergent resistance types
Date and time: Sunday, April 22 from 1:30 – 2:30 p.m. CEST
Location: Paper Poster Arena
Poster number: #P1156
Session information: Diverse mechanisms of resistance - Gram negatives
TP-6076 poster presentation
Poster title: Activity of TP-6076 against carbapenem-resistant Acinetobacter baumannii isolates collected from inpatients in Greek hospitals
Date and time: Saturday, April 21 from 3:30-4:30 p.m. CEST
Location: Paper Poster Arena
Poster number: #P0106
Session information: Activity of new or re-purposed non-beta lactam drugs against Gram-negatives
Additional Activities:
- Tetraphase will be hosting an Exhibit Booth (#5A) at ECCMID 2018 from 12:00 to 6:00 p.m. CEST on Saturday, April 21; 9:30 a.m. to 5:00 p.m. CEST on Sunday, April 22 and Monday, April 23; and 9:30 a.m. to 2:00 p.m. CEST on Tuesday, April 24.
- Tetraphase has provided an independent educational grant in support of a Continuing Medical Education Symposium entitled "Emerging options for complicated Gram-negative infections: considerations for intra-abdominal and urinary tract infections.” It will take place on Monday, April 23, from 4:00 to 6:00 pm CEST at the ECCMID 2018 venue, IFEMA – Feria de Madrid, Hall R.
Full abstracts can be found on the ECCMID website at www.eccmid.org.
About Tetraphase Pharmaceuticals, Inc.
Tetraphase is a 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 MDR bacteria highlighted as urgent public health threats by the Centers for Disease and Control. The Company has created more than 3,000 novel tetracycline analogs using its proprietary technology platform. Tetraphase's pipeline includes three antibiotic clinical candidates: eravacycline, which has completed phase 3 clinical trials and is under review for potential approval in complicated intra-abdominal infections by the Food and Drug Administration and the European Medicines Agency, and TP-271 and TP-6076, which are in phase 1 clinical trials. Eravacycline is an investigational product only and has not been approved for commercialization. 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 the Company's regulatory submission will receive approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; whether, if any clinical candidate, including eravacycline obtains approval, it will be successfully distributed and marketed; and other factors discussed in the "Risk Factors" section of our annual report on Form 10-K for the year ended December 31, 2017, filed with the Securities and Exchange Commission on March 6, 2018. In addition, the forward-looking statements included in this press release represent our views as of April 12, 2018. 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.
Media and Investor Contact:
Jennifer Viera
jviera@tphase.com
617-600-7040