Tetraphase Pharmaceuticals Announces Submission and Validation of IV Eravacycline Marketing Authorization Application by European Medicines Agency
"The MAA filing represents a significant milestone for Tetraphase as it is our first regulatory application for marketing authorization and a major step toward making eravacycline available as a new antibiotic treatment option for patients with serious hospital infections," said
Eravacycline is a novel,
fully-synthetic fluorocycline antibiotic being developed for the treatment of serious infections, including those caused by multidrug-resistant (MDR) pathogens that have been highlighted as urgent public health threats by both the
Eravacycline is currently being investigated in the Company's phase 3 IGNITE (Investigating Gram-negative Infections Treated with Eravacycline) program. To date, eravacycline has been administered to over 1,500 patients and in two completed phase 3 trials in cIAI. In IGNITE1, twice-daily IV eravacycline met the primary endpoint by demonstrating statistical non-inferiority of clinical response compared to ertapenem, was well tolerated, and achieved high cure rates in patients with Gram-negative pathogens, including resistant isolates. The IGNITE1 data is serving as the basis of the MAA for IV eravacycline for the treatment of patients with cIAI now under review by the EMA. In IGNITE4, a second phase 3 clinical trial in patients with cIAI, twice-daily IV eravacycline met the primary endpoint by demonstrating statistical non-inferiority of clinical response compared to meropenem, was well tolerated, and achieved high cure rates. The Company plans to use the results from IGNITE1 and IGNITE4 to support an NDA submission for IV eravacycline in cIAI. Tetraphase is also currently conducting IGNITE3, an additional phase 3 trial evaluating once-daily IV eravacycline in patients with cUTI and, assuming a positive outcome, the Company plans to use the results from IGNITE3 to support a supplemental NDA submission for eravacycline in cUTI. In parallel, Tetraphase is continuing its efforts to develop an oral dose formulation of eravacycline. A phase 1 clinical program is ongoing which is designed to evaluate and optimize the oral dosing regimen for eravacycline.
About Complicated Intra-abdominal Infections (cIAI)
Intra-abdominal infection (IAI) is a common problem in clinical practice and comprises a wide variety of disease processes. IAI is classified as uncomplicated or complicated based on the extent of the infection. Complicated intra-abdominal infection extends beyond the source organ into the peritoneal space (the space between the two membranes that separate the organs in the abdominal cavity from the abdominal wall) as a result of perforation or other damage to the gastrointestinal tract. cIAI diagnoses include intra-abdominal abscess, stomach or intestinal perforation, peritonitis, appendicitis, cholecystitis, or diverticulitis. Different bacterial pathogens are responsible for cIAI, including Gram-negative aerobic bacteria, Gram-positive bacteria, and anaerobic bacteria, and there are also mixed infections. IAI is an important cause of morbidity and mortality and is the second most common cause of infectious mortality in the intensive care unit. Early detection, containment and appropriate antimicrobial treatment are essential to the successful treatment of IAI. This is even more critical with increasing rates of infections caused by drug-resistant bacteria, which limit the effectiveness of currently available antibiotics.
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
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 previous 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 or at all; whether the results of the Company's development efforts will warrant regulatory submission and whether any such submissions will receive approval from the
Tetraphase Pharmaceuticals Teri Dahlman617-600-7040 firstname.lastname@example.org Argot Partners Maeve Conneighton206.899.4940 email@example.com Media Contact: Sam Brown Inc. Mike Beyer312-961-2502 Mikebeyer@sambrown.com
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