Tetraphase Pharmaceuticals to Present Data at the 22nd Annual MAD-ID Meeting

Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a biopharmaceutical company focused on developing and commercializing novel tetracyclines to treat serious and life-threatening conditions, today announced five data presentations at the 22nd Annual MAD-ID (Making a Difference in Infectious Diseases) Meeting, taking place May 8-11, 2019 in Orlando, Fla.

WATERTOWN, Mass.--(BUSINESS WIRE)-- Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a biopharmaceutical company focused on developing and commercializing novel tetracyclines to treat serious and life-threatening conditions, today announced five data presentations at the 22nd Annual MAD-ID (Making a Difference in Infectious Diseases) Meeting, taking place May 8-11, 2019 in Orlando, Fla. 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.

The details for the data presentations at MAD-ID are as follows:

Poster title: Eravacycline is Effective in High-Risk Complicated Intra-Abdominal Infection Subgroups
Date and time: Thursday, May 9 from 5:00 – 6:30 p.m. ET
Location: Grand Ballroom CDE
Poster number: 75 E

Poster title: Efficacy of Eravacycline in Obese Patients: Pooled Analysis of IGNITE1 and IGNITE4
Date and time: Thursday, May 9 from 5:00 – 6:30 p.m. ET
Location: Grand Ballroom CDE
Poster number: 74 E

Poster title: Effect of Renal Function in IGNITE1 and IGNITE 4: Two Phase 3 Studies to Evaluate the Efficacy and Safety of Eravacycline
Date and time: Thursday, May 9 from 5:00 – 6:30 p.m. ET
Location: Grand Ballroom CDE
Poster number: 73 E

Poster title: Micro Efficacy of Eravacycline Against Enterobacteriaceae and Acinetobacter, Including MDR Isolates: A Pooled Analysis from IGNITE1 and IGNITE4
Date and time: Thursday, May 9 from 5:00 – 6:30 p.m. ET
Location: Grand Ballroom CDE
Poster number: 76 E

Poster title: Multi-Site Evaluation of Eravacycline MIC Test Strip Compared to Broth Microdilution for Enterobacteriaceae, S. aureus and Enterococcus spp.
Date and time: Thursday, May 9 from 5:00 – 6:30 p.m. ET
Location: Grand Ballroom CDE
Poster number: 72 OR

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 8 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 8 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

This press release contains forward-looking statements including statements related to our overall strategy, products, prospects and potential. All statements, other than statements of historical facts, included in this press release are forward-looking statements, and are identified by words such as “advancing,” “expect,” “look forward,” “anticipate,” “continue,” and other words and terms of similar meaning. These forward-looking statements are based upon our current expectations and involve substantial risks and uncertainties. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements and you should not place undue reliance on these forward-looking statements. Our actual results and the timing of events could differ materially from those included in such forward-looking statements as a result of these risks and uncertainties. These and other risk factors are discussed under “Risk Factors” and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2018, filed with the Securities and Exchange Commission on March 15, 2019. In addition, the forward-looking statements included in this press release represent our views as of May 2, 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.

Contacts

Media and Investor Contact:
Jennifer Viera
jviera@tphase.com
617-600-7040

Source: Tetraphase Pharmaceuticals, Inc.

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