Tetraphase Pharmaceuticals Highlights Data at Upcoming American Society for Microbiology Microbe 2019 Annual Meeting

Date : 06/13/2019 @ 12:00PM
Source : Business Wire
Stock : Tetraphase Pharmaceuticals Inc (TTPH)
Quote : 4.62  0.0 (0.00%) @ 12:28PM

Tetraphase Pharmaceuticals Highlights Data at Upcoming American Society for Microbiology Microbe 2019 Annual Meeting

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Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a biopharmaceutical company focused on developing and commercializing novel tetracyclines to treat serious and life-threatening conditions, today announced that new data will be presented at the American Society for Microbiology (ASM) Microbe 2019 Annual Meeting, taking place June 20-24 in San Francisco. Presentations will include data on XERAVATM (eravacycline), a novel, fully synthetic fluorocycline approved by the U.S. Food and Drug Administration and the European Medicines Agency for the treatment of complicated intra-abdominal infections (cIAI), and TP-6076, a clinical-stage candidate in development to target multidrug-resistant infections.

The details for the presentations at ASM Microbe are as follows:

Poster title: Global In Vitro Surveillance of Eravacycline Against Gram-Negative and Gram-Positive Clinical Isolates, Including Multidrug-Resistant Pathogens, Collected in 2017Presenter: Sara Hwang, Pharm.D.Track: Antimicrobial Agents and ResistanceSub-track: AAR01 – Surveillance of Antimicrobial Resistance: Molecular Typing/Clinical and Molecular EpidemiologyDate and time: Friday, June 21 from 10:30 a.m. – 5:00 p.m. PTSession type: Poster PresentationPoster number: AAR-543

Poster title: Activity of Eravacycline and Comparators Against 15,887 Bacterial Pathogens Isolated From Patients Receiving Care in Canadian Hospitals: CANWARD 2014-2018Presenter: George G. Zhanel, Pharm.D., Ph.D.Track: Antimicrobial Agents and ResistanceSub-track: AAR09 – Pharmacological Studies of Investigational Agents Pre-NDA (Phase 2/3)Date and time: Saturday, June 22 from 10:30 a.m. – 5:00 p.m. PTSession type: Poster PresentationPoster number: AAR-790

Poster title: Multicenter Evaluation of Eravacycline MIC Results for Enterobacteriaceae Using MicroScan Dried Gram-Negative MIC PanelsPresenter: Jennifer Y. Chau, Ph.D.Track: Clinical and Public Health MicrobiologySub-track: CPHM02 – Antimicrobial Susceptibility TestingDate and time: Sunday, June 23 from 10:30 a.m. – 4:00 p.m. PTSession type: Poster PresentationPoster number: CPHM-862

Poster title: First Comparative Evaluation of ETEST® ERV bioMérieux With the CLSI Broth Microdilution Method for Eravacycline MIC DeterminationPresenter: Edwige Pillon, bioMérieux S.A.; Marcy l’Etoile, FranceTrack: Clinical and Public Health MicrobiologySub-track: CPHM02 – Antimicrobial Susceptibility TestingDate and time: Sunday, June 23 from 10:30 a.m. – 4:00 p.m. PTSession type: Poster PresentationPoster number: CPHM-865

Poster title: Activity of Cefiderocol (CFDC), Ceftazidime-Avibactam (CZA), and Eravacycline (ERV) Against Carbapenem-Resistant (CR) E. coli Isolates From the U.S.: Clonal Background, Resistance Genes, and Co-ResistancePresenter: Brian D. JohnstonTrack: Antimicrobial Agents and ResistanceSub-track: AAR09 – Pharmacological Studies of Investigational Agents Pre-NDA (Phase 2/3)Date and time: Saturday, June 22 from 10:30 a.m. – 5:00 p.m. PTSession type: Poster PresentationPoster number: AAR-768

Poster title: Efficacy of TP-6076 in the Murine Thigh Infection Model With Acinetobacter baumanniiPresenter: Mark E. PulseTrack: Antimicrobial Agents and ResistanceSub-track: AAR08 – New Antimicrobial Agents (In Vitro and In Vivo Studies Prior to the Start of Clinical Therapy)Date and time: Friday, June 21 from 10:30 a.m. – 5:00 p.m. PTSession type: Poster PresentationPoster number: AAR-787

Poster title: Pharmacokinetics and Efficacy of TP-6076 in the Murine Lung Infection Model With Acinetobacter baumanniiPresenter: William J. Weiss, M.S.Track: Antimicrobial Agents and ResistanceSub-track: AAR08 – New Antimicrobial Agents (In Vitro and In Vivo Studies Prior to the Start of Clinical Therapy)Date and time: Friday, June 21 from 10:30 a.m. – 5:00 p.m. PTSession type: Poster PresentationPoster number: AAR-788

Symposium Presentation: Pharmacokinetics and Efficacy of TP-6076 in the Murine Lung Infection Model With Acinetobacter baumanniiPresenter: William J. Weiss, M.S.Track: Antimicrobial Agents and ResistanceSub-track: AAR09 – Pharmacological Studies of Investigational Agents Pre-NDA (Phase 2/3)Date and time: Sunday, June 23 from 3:30 p.m. – 3:45 p.m. PTSession: S339 – Pipeline Drugs to Treat Gram-negative Infections

Additional Activities:

  • Tetraphase will host a XERAVA exhibit booth (#343) at ASM during exhibit hours.

About XERAVATM

XERAVA (eravacycline for injection) is a tetracycline class antibacterial indicated for the treatment of complicated intra-abdominal infections (cIAI) in patients 18 years of age and older. XERAVA was investigated for the treatment of cIAI as part of the Company's IGNITE (Investigating Gram-Negative Infections Treated with Eravacycline) Phase 3 program. In the first pivotal Phase 3 trial in patients with cIAI, twice-daily intravenous (IV) XERAVA met the primary endpoint by demonstrating statistical non-inferiority of clinical response compared to ertapenem and was well-tolerated. In the second Phase 3 clinical trial in patients with cIAI, twice-daily IV XERAVA met the primary endpoint by demonstrating statistical non-inferiority of clinical response compared to meropenem and was well-tolerated. In both trials, XERAVA achieved high cure rates in patients with Gram-negative pathogens, including resistant isolates.

Indications and Usage

XERAVA is indicated for the treatment of complicated intra-abdominal infections (cIAI) caused by susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii, Enterobacter cloacae, Klebsiella oxytoca, Enterococcus faecalis, Enterococcus faecium, Staphylococcus aureus, Streptococcus anginosus group, Clostridium perfringens, Bacteroides species, and Parabacteroides distasonis in patients 18 years or older.

Limitations of Use

XERAVA is not indicated for the treatment of complicated urinary tract infections (cUTI).

Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of XERAVA and other antibacterial drugs, XERAVA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Important Safety Information

XERAVA is contraindicated for use in patients with known hypersensitivity to eravacycline, tetracycline-class antibacterial drugs, or to any of the excipients. Life-threatening hypersensitivity (anaphylactic) reactions have been reported with XERAVA.

The use of XERAVA during tooth development (last half of pregnancy, infancy and childhood to the age of eight years) may cause permanent discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia.

The use of XERAVA during the second and third trimester of pregnancy, infancy and childhood up to the age of eight years may cause reversible inhibition of bone growth.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis.

The most common adverse reactions observed in clinical trials (incidence ≥3%) were infusion site reactions (7.7%), nausea (6.5%), and vomiting (3.7%).

XERAVA is structurally similar to tetracycline-class antibacterial drugs and may have similar adverse reactions. Adverse reactions including photosensitivity, pseudotumor cerebri, and anti-anabolic action which has led to increased BUN, azotemia, acidosis, hyperphosphatemia, pancreatitis, and abnormal liver function tests, have been reported for other tetracycline-class antibacterial drugs, and may occur with XERAVA. Discontinue XERAVA if any of these adverse reactions are suspected.

To report SUSPECTED ADVERSE REACTIONS, contact Tetraphase Pharmaceuticals Inc., at 1-833-7-XERAVA (1-833-793-7282) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information for XERAVA at www.XERAVA.com.

About Tetraphase Pharmaceuticals, Inc.

Tetraphase Pharmaceuticals, Inc., is a biopharmaceutical company using its proprietary chemistry technology to create novel tetracyclines for serious and life-threatening conditions, including infections caused by many of the multidrug-resistant bacteria highlighted as urgent public health threats by the World Health Organization and the Centers for Disease Control and Prevention. The Company has created more than 3,000 novel tetracycline compounds using its proprietary technology platform. Tetraphase's lead product XERAVATM is approved for the treatment of complicated intra-abdominal infections by the U.S. Food and Drug Administration and the European Medicines Agency. The Company’s pipeline also includes TP-271 and TP-6076, which are in Phase 1 clinical trials, and TP-2846, which is in preclinical testing for acute myeloid leukemia. 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, including our key milestones for 2019 and our anticipated cash runway, 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 clinical, regulatory and commercial risk factors discussed in the "Risk Factors" section of our quarterly report on Form 10-Q for the period ended March 31, 2019, filed with the Securities and Exchange Commission on May 8, 2019. In addition, the forward-looking statements included in this press release represent our views as of June 13, 2019. 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:Argot PartnersMaeve Conneighton212-600-1902maeve@argotpartners.com

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