GlobeNewswire

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

Dela

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

GlobeNewswire



Följ GlobeNewswire

Abonnera på våra pressmeddelanden.

Senaste pressmeddelandena från GlobeNewswire

Immunicum AB (publ) Announces Publication of Phase I/II Clinical Trial Results of Ilixadencel in Advanced Hepatocellular Carcinoma in Frontiers in Oncology21.1.2019 08:30Pressmeddelande

Press Release 21 January 2019 Immunicum AB (publ) Announces Publication of Phase I/II Clinical Trial Results of Ilixadencel in Advanced Hepatocellular Carcinoma in Frontiers in Oncology Immunicum AB (publ; IMMU.ST) announced today that the final data analysis from the exploratory clinical study of ilixadencel in patients with advanced hepatocellular carcinoma (HCC) has been published in the journal, Frontiers in Oncology . The data confirms previously communicated positive safety and tolerability of ilixadencel when administered both alone and in combination with current first-line standard of care, sorafenib. In addition, the data demonstrate an increased frequency of tumor-specific CD8+ T cells in circulating blood for a majority of evaluable patients, indicating a systemic immune response. The complete results provide further insight on ilixadencel's mode of action, signs of clinical activity and important information that will guide the next stage of clinical development. As commun

Immunicum AB (publ) meddelar att resultaten från den kliniska fas I/II-studien med ilixadencel vid långt framskriden levercancer publicerats i Frontiers in Oncology21.1.2019 08:30Pressmeddelande

Pressmeddelande 21 januari 2019 Immunicum AB (publ) meddelar att resultaten från den kliniska fas I/II-studien med ilixadencel vid långt framskriden levercancer publicerats i Frontiers in Oncology Immunicum AB (publ; IMMU.ST) meddelar idag att den slutliga analysen av data från den undersökande kliniska studien med ilixadencel hos patienter med långt framskriden levercancer har publicerats i tidskriften, Frontiers in Oncology . Dessa data bekräftar de tidigare meddelade positiva egenskaperna gällande säkerhet och tolerabilitet för ilixadencel, både när det ges som enda behandling och i kombination med första linjens standardbehandling, sorafenib. Dessutom påvisades ökade nivåer av tumörspecifika CD8+ T-celler i cirkulerande blod för en majoritet av de utvärderbara patienterna, vilket indikerar ett systemiskt immunologiskt svar. De fullständiga resultaten ger ytterligare insikter om ilixadencels verkningsmekanism, tecken på klinisk effekt samt viktig information som kommer att vara vägl

Karolinska Development's portfolio company Modus Therapeutics completes enrollment in Phase II study with sevuparin7.1.2019 12:00Pressmeddelande

STOCKHOLM, January 7, 2019. Karolinska Development's portfolio company Modus Therapeutics announces that the patient enrollment has been completed in the Phase II study with sevuparin in patients with sickle cell disease (SCD). The results from the study is expected in mid 2019. Modus Therapeutic's randomized, double blind study contains 140 SCD-patients with Acute Vaso Occlusive Crisis (VOC). It compares intravenously administered sevuparin with placebo. The primary endpoint of the study is the demonstration of a reduced time to resolution of patient's VOC. Clincal sites across Europe and the Middle East took part in the study that was conducted in conjunction with Modus Therapeutics' co development partner Ergomed. SCD has a high unmet medical need as there are currently no approved therapies for VOCs. It is an inherited blood disorder that affects between 90,000 to 100,000 patients in the U.S. and is characterized by severely painful VOCs that lead to organ damage due to a lack of o

Karolinska Development's portfolio company Modus Therapeutics completes enrollment in Phase II study with sevuparin7.1.2019 12:00Pressmeddelande

STOCKHOLM, January 7, 2019. Karolinska Development's portfolio company Modus Therapeutics announces that the patient enrollment has been completed in the Phase II study with sevuparin in patients with sickle cell disease (SCD). The results from the study is expected in mid 2019. Modus Therapeutic's randomized, double blind study contains 140 SCD-patients with Acute Vaso Occlusive Crisis (VOC). It compares intravenously administered sevuparin with placebo. The primary endpoint of the study is the demonstration of a reduced time to resolution of patient's VOC. Clincal sites across Europe and the Middle East took part in the study that was conducted in conjunction with Modus Therapeutics' co development partner Ergomed. SCD has a high unmet medical need as there are currently no approved therapies for VOCs. It is an inherited blood disorder that affects between 90,000 to 100,000 patients in the U.S. and is characterized by severely painful VOCs that lead to organ damage due to a lack of o

Stillfront Group announces Head of M&A19.12.2018 12:07Pressmeddelande

PRESS RELEASE December 19, 2018 Stillfront Group announces Head of M&A Stillfront Group, a market leader in 'free to play' online strategy games, today announces that Marina Andersson has been appointed as Head of M&A and will be part of the Group's management team. Marina has close to 20 years track record of investment banking and M&A. She has extensive competence within strategic and financial advisory, deal generation, buy and sell side M&A project management, financial analysis, due diligence and company valuation. Former positions include: Director at Deloitte's Corporate Finance Advisory team, Director at ICECAPITAL Securities, Associate Partner and Investment Manager at Deseven, M&A Analyst at Carnegie. She holds two Master degrees from Stockholm University and Russian Herzen State Pedagogical University. "Acquisitions are a crucial part of Stillfront's business strategy and we are very pleased with the appointment of Marina Andersson. Marina's breadth of experience and profess

Stillfront Group rekryterar ansvarig för M&A19.12.2018 12:07Pressmeddelande

PRESSMEDDELANDE 19 december, 2018 Stillfront Group rekryterar ansvarig för M&A Stillfront Group, en marknadsledare inom 'free to play' online strategispel, annonserar idag att Marina Andersson har utsetts till ansvarig för M&A och kommer att ingå i koncernledningen. Marina har närmare tjugo års erfarenhet från investment banking och M&A. Hon har omfattande erfarenhet inom strategisk och finansiell rådgivning, affärsgenerering, projektledning inom förvärv och försäljningar av företag, finansiell analys, due diligence, samt företagsvärdering. Tidigare positioner inkluderar: Director, Deloitte's Corporate Finance Advisory team, Director, ICECAPITAL Securities, Associate Partner och Investment Manager, Deseven, samt M&A Analytiker på Carnegie. Marina har två magister-examen från Stockholms universitet och Russian Herzen State Pedagogical University. "Förvärv är en viktig del av Stillfronts affärsstrategi och vi är mycket glada att rekrytera Marina Andersson. Marinas breda erfarenhet och pr

I vårt pressrum kan du läsa de senaste pressmeddelandena, få tillgång till pressmaterial och hitta kontaktinformation.

Besök vårt pressrum