Nasdaq GlobeNewswire

Tetraphase Pharmaceuticals Announces Submission and Validation of IV Eravacycline Marketing Authorization Application by European Medicines Agency

Del

WATERTOWN, Mass., Aug. 17, 2017 (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 the Marketing Authorization Application (MAA) for IV eravacycline for the treatment of complicated intra-abdominal infections (cIAI) has been submitted and was validated by the European Medicines Agency (EMA). Eravacycline is a novel, fully-synthetic fluorocycline antibiotic being developed for the treatment of serious infections, including those caused by multidrug-resistant (MDR) pathogens. The MAA filing is based on data from the phase 3 IGNITE1 clinical trial in which eravacycline was well tolerated and demonstrated statistical non-inferiority to ertapenem using the primary endpoint of clinical response at the test-of-cure (TOC) visit.

"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 Guy Macdonald, President and Chief Executive Officer of Tetraphase. "I am proud of the dedicated team at Tetraphase who made this  happen and who support our commitment to develop novel antibiotics to treat drug-resistant infections. We look forward to working with the EMA during their review of this application and to focusing on the submission of the New Drug Application to the U.S. Food and Drug Administration in the first quarter of 2018."

About Eravacycline

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 World Health Organization and the U.S. Centers for Disease Control (CDC). Eravacycline has demonstrated potent activity against multidrug-resistant (MDR) pathogens, including carbapenem-resistant enterobacteriaceae (CRE), Acinetobacter baumannii, and colistin-resistant bacteria carrying the mcr-1 gene.  Eravacycline is in phase 3 clinical development for the treatment of complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI).

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.

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 three antibiotic clinical candidates: eravacycline, which is in phase 3 clinical trials, and TP-271 and TP-6076, which are in phase 1 clinical trials. 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  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 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 August 2, 2017. In addition, the forward-looking statements included in this press release represent our views as of August 17, 2017. 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 
Maeve Conneighton 
206.899.4940
maeve@argotpartners.com

Media Contact: 
Sam Brown Inc.
Mike Beyer
312-961-2502
Mikebeyer@sambrown.com




This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Tetraphase Pharmaceuticals via Globenewswire

Om Nasdaq GlobeNewswire

Nasdaq GlobeNewswire
Nasdaq GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York

+1 212 401 8700http://www.nasdaqomx.com

NASDAQ (NASDAQ: NDAQ) is a leading provider of trading, exchange technology, information and public company services across six continents.

Følg saker fra Nasdaq GlobeNewswire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Nasdaq GlobeNewswire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Nasdaq GlobeNewswire

SEMAFO Mourns Passing of Board Chairman Jean Lamarre23.11.2017 22:01Pressemelding

MONTREAL, Nov. 23, 2017 (GLOBE NEWSWIRE) -- SEMAFO (TSX:SMF) (OMX:SMF) announces with sadness the passing of Mr. Jean Lamarre, Chairman of the Board of Directors of the Corporation, on November 22, 2017 following a short illness. Mr. Lamarre joined the Corporation's Board of Directors in 1997 and was appointed Chairman of the Board in 2000, a position he held until his demise. "Jean made an indelible mark on SEMAFO, both in terms of his corporate governance expertise and his 45 years of experience in Africa," said President and CEO Benoit Desormeaux. "Over his 20-year tenure with SEMAFO, he brought unique insight, business acumen and leadership to the Corporation as it transitioned from an exploration company to a junior gold producer. He did this, always without compromising his values: the integrity of the Corporation, his deep love for Africa and its people, and his priority to SEMAFO's long-term sustainability. On behalf of SEMAFO's Board of Directors, management and employe

Premier to join industry leaders at BDA London forum23.11.2017 21:39Pressemelding

HAMILTON, Bermuda, Nov. 23, 2017 (GLOBE NEWSWIRE) -- Premier David Burt will join more than two-dozen Bermuda executives in a multi-industry forum being held in London next week to showcase the breadth of expertise and advantages offered by the island's global business market. A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/78c5ac53-07f7-4dd8-83e0-753ea5b4c80b Organised by the Bermuda Business Development Agency (BDA), the one-day event Tuesday, November 28 at ME London has attracted over 200 registrants. It will feature top regulatory and industry leaders in moderated discussion panels covering re/insurance, captive insurance, insurance-linked securities, asset management, family offices, and trust and private-client business. A networking reception will wrap the event in the evening. "The government supports the Bermuda Business Development Agency in this awareness-raising event that offers such gre

Crown Bioscience and Data Sciences International (DSI) Partner to Advance Metabolic Disease Research Using an Implanted Telemetry Device for Long-Term Blood Glucose Monitoring23.11.2017 14:00Pressemelding

SANTA CLARA, Calif., Nov. 23, 2017 (GLOBE NEWSWIRE) -- Crown Bioscience, a wholly-owned subsidiary of Crown Bioscience International (TWSE: ticker 6554) and a global drug discovery and development services company providing translational platforms to advance oncology, inflammation cardiovascular and metabolic disease research, announces the successful development of an enhanced method for preclinical obesity and type 2 diabetes studies in partnership with Data Sciences International (DSI). Crown Bioscience's clinically relevant models and DSI's HD-XG implantable glucose device combine to create a superior approach to preclinical metabolic disease research. Recently published work in the Journal of Endocrinological Investigation and Nature's Scientific Reports demonstrates the advantages of a new method using DSI's HD-XG implantable glucose device and Crown Bioscience's models of spontaneous and diet-induced diabetes. The HD-XG device allows for continuous, long-term measurement

Euroloan Opens New Market in Spain23.11.2017 11:10Pressemelding

Helsinki, Finland, 2017-11-23 11:10 CET (GLOBE NEWSWIRE) -- According to James Hickson, CEO of Euroloan Group, initiating services in the Spanish market is a key step in the expansion strategy of the Fintech group. “We have seen a growing demand for easy payment solutions in several markets, and the Spanish market in particular offers a massive opportunity for growth with Euroloan’s advanced payment and credit solutions. Merchants and Consumers appreciate our simple, fast and efficient services. It’s all about making their life easier. Consistent with our strategy, we have identified a number of partners to accelerate our market entry approach and expect to be providing our lending and merchant solutions by the end of the 1Q 2018” The Group is now present in five countries in Europe, including Finland, Sweden, Poland, Luxembourg and Spain. “Euroloan aims to open up several additional new markets”, says Tommi Lindfors, Chairman of the Board of Euroloan Group. “Spain is an importan

BDA partners with government to attract cryptocurrency23.11.2017 06:25Pressemelding

HAMILTON, Bermuda, Nov. 23, 2017 (GLOBE NEWSWIRE) -- The Bermuda Business Development Agency (BDA) will take a lead role in an initiative launched by the Bermuda government today to accelerate the establishment and growth of digital currency business on the island. A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/457f43b9-d7bb-48f1-83e2-b856b33ebacc At a press conference held by Premier the Hon David Burt and National Security Minister the Hon Wayne Caines, the government announced the formation of a task force comprising two teams to advance Bermuda's regulatory environment as a destination for utility tokens, tokenised securities, cryptocurrencies, and coin offerings. BDA Consultant for Emerging Technologies John Narraway was named as chair of the Blockchain Business Development Working Group, while BDA Board member Lydia Dickens will chair the Blockchain Legal and Regulatory Working Group, of which

VistaJet Partners With Christie's for the Global Tour of The Collection of Peggy and David Rockefeller22.11.2017 11:39Pressemelding

The sale will be the most significant philanthropic auction ever presented LONDON, Nov. 22, 2017 (GLOBE NEWSWIRE) -- VistaJet, the first and only global private aviation company, announces today its worldwide sponsorship of the exhibition and tour of The Collection of Peggy and David Rockefeller, the most significant auction entirely dedicated to raising funds for philanthropic causes.  The sale, consisting of numerous categories, will be conducted by Christie's, the world's leading art business, and will include a highlights exhibition tour in Hong Kong, London, Los Angeles and New York. Photos accompanying this announcement are available at http://www.globenewswire.com/NewsRoom/AttachmentNg/c78fdce7-7651-42a8-a621-14088da2cc86 http://www.globenewswire.com/NewsRoom/AttachmentNg/33af2489-a9a8-4bbe-b5f7-78e4c1f29ca2 http://www.globenewswire.com/NewsRoom/AttachmentNg/a16c2

I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.

Besøk vårt presserom