Nabriva to Present Data from XENLETA (lefamulin) and CONTEPO (fosfomycin) Development Programs at IDWeek 2019

DUBLIN, Ireland, Sept. 26, 2019 (GLOBE NEWSWIRE) — Nabriva Therapeutics plc (NASDAQ: NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, announced today that data from its XENLETA™ (lefamulin) and CONTEPO™ (fosfomycin) clinical development programs will be presented at IDWeek 2019, to be held October 2-9 in Washington, D.C.

Nabriva, along with its collaborators, will present a total of 14 posters, including 11 for lefamulin and three for fosfomycin. Lefamulin data being presented has been generated from the company’s community-acquired bacterial pneumonia (CABP) clinical trial and in vitro surveillance programs. In addition, the company will present clinical data for CONTEPO from the Phase 2/3 pivotal study for the treatment of complicated urinary tract infections (cUTIs) as well as epidemiologic and prevalence data of U.S. hospitalized patients with difficult-to-treat, drug-resistant uropathogens, e.g., Enterobacteriaciae and P. aeruginosa.

XENLETA is the first oral and intravenous (IV) treatment in the pleuromutilin class of antibiotics. XENLETA was approved by the U.S. Food and Drug Administration (FDA) on August 19, 2019 for the treatment of adults with CABP and is now commercially available in the United States. Nabriva plans to resubmit the new drug application (NDA) for CONTEPO early in the fourth quarter of 2019.

“We are excited to share our latest clinical data on the safety and efficacy of XENLETA and CONTEPO with the infectious disease community at IDWeek,” said Jennifer Schranz MD, Chief Medical Officer of Nabriva Therapeutics. “Our rigorous clinical trial programs continue to generate meaningful information that we believe will aid clinicians in determining the most appropriate treatment choice for their patients with CABP or cUTIs. We are proud to be working to provide patients and the infectious diseases community two new antibiotics with critically needed novel mechanisms of action that address several of the Centers for Disease Control (CDC) Urgent Threat and World Health Organization (WHO) priority pathogens.”

PRESENTATIONS SCHEDULED FOR THURSDAY, OCTOBER 3, 2019
12:15 p.m. – 1:30 p.m. (EDT) 

Presentation Title: Efficacy and Safety of Lefamulin (LEF) Versus Moxifloxacin (MOX) for Legionella pneumophila (LP) in Patients (Pts) With Community-Acquired Bacterial Pneumonia (CABP): Pooled Results From the Lefamulin Evaluation Against Pneumonia (LEAP) 1 and LEAP 2 Phase 3 Clinical Trials
Poster #: 663
Presenter: E. Alexander

Presentation Title: Efficacy in Adults With Moderate to Severe Community-Acquired Bacterial Pneumonia (CABP) and Pneumonia Outcomes Research Team (PORT) Risk Class III to V: Results of a Pooled Analysis of Lefamulin Evaluation Against Pneumonia (LEAP) 1 and LEAP 2 Study Outcomes
Poster #: 664
Presenter: E. Alexander

Presentation Title: Health-Related Quality of Life (HRQoL) as Measured by the 12-Item Medical Outcomes Study Short-Form (SF-12) Among Adults With Community-Acquired Bacterial Pneumonia (CABP) Who Received Either Lefamulin (LEF) or Moxifloxacin (MOX) in Two Phase 3 Randomized, Double-Blind, Double-Dummy Clinical Trials (LEAP 1 and 2)
Poster #: 676
Presenter: T. Lodise

Presentation Title: Cardiac Safety in Adults With Community-Acquired Bacterial Pneumonia (CABP) Treated With Lefamulin (LEF) or Moxifloxacin (MOX): Analysis of Lefamulin Evaluation Against Pneumonia (LEAP) 1 and LEAP 2 Study Results
Poster #: 684
Presenter: D. Stein

Presentation Title: Hepatobiliary Safety in Adults With Community-Acquired Bacterial Pneumonia (CABP) Treated With Lefamulin (LEF) or Moxifloxacin (MOX): Pooled Analysis of Lefamulin Evaluation Against Pneumonia (LEAP) 1 and LEAP 2 Study Results
Poster #: 699
Presenter: J. Schranz

Presentation Title: In Vitro Activity of Lefamulin Against Bacterial Pathogens Causing Community-Acquired Bacterial Pneumonia (CABP): SENTRY Surveillance 2017–2018 Results From the United States (US)
Poster #: 703
Presenter: H.S. Sader

Presentation Title: Pharmacokinetics (PK) and Safety of Lefamulin (LEF) After Single Intravenous Dose Administration in Subjects With Impaired Renal Function and in Those Requiring Hemodialysis
Poster #: 705
Presenter: D. Mariano

Presentation Title: Lefamulin (LEF) Versus Moxifloxacin (MOX) in Patients With Community-Acquired Bacterial Pneumonia (CABP) at Risk for Poor Efficacy or Safety Outcomes: Pooled Subgroup Analyses From the Lefamulin Evaluation Against Pneumonia (LEAP) 1 and LEAP 2 Phase 3 Noninferiority Clinical Trials
Poster #: 717
Presenter: J. Schranz

Presentation Title: Pharmacokinetics (PK) and Safety of Lefamulin (LEF) After Single Intravenous Dose Administration in Subjects With Impaired Hepatic Function
Poster #: 722
Presenter: W.W. Wicha

Presentation Title: Efficacy of Fosfomycin for Injection (FOS) vs Piperacillin-Tazobactam (PIP-TAZ) in Adults With Complicated Urinary Tract Infection (cUTI) and Acute Pyelonephritis (AP): ZEUS Study Outcomes in Patients With Reduced Study Drug Susceptibility
Poster #: 720
Presenter: E.J. Ellis-Grosse

PRESENTATIONS SCHEDULED FOR FRIDAY, OCTOBER 4, 2019
12:15 p.m. – 1:30 p.m. (EDT) 

Presentation Title: Prevalence and Regional Variation of in ESBLs and CRE Enterobacteriaceae (ENT) among Adult, Hospitalized Patients with ENT on a Urine Culture: A Multicenter Evaluation
Poster #: 1440
Presenter: V. Gupta

Presentation Title: Trends in Important Resistant Gram-negative (GN) and Gram-positive (GP) Urine Bacterial Pathogens in Hospitalized Patients in the US: A Multicenter Evaluation from 2013-2018
Poster #: 1485
Presenter: V. Gupta

PRESENTATIONS SCHEDULED FOR SATURDAY, OCTOBER 5, 2019
12:15 p.m. – 1:30 p.m. (EDT) 

Presentation Title: Efficacy and Symptom Resolution by Visit in Adults With Community-Acquired Bacterial Pneumonia (CABP) Treated With Lefamulin (LEF) or Moxifloxacin (MOX): Pooled Analysis of Lefamulin Evaluation Against Pneumonia (LEAP) 1 and LEAP 2 Study Results
Poster #: 2233
Presenter: E. Alexander

Presentation Title: Oral 5-Day Lefamulin for Outpatient Management of Pneumonia Outcomes Research Team (PORT) Risk Class III/IV Community-Acquired Bacterial Pneumonia (CABP): Post Hoc Analysis of the Lefamulin Evaluation Against Pneumonia (LEAP) 2 Phase 3 Study
Poster #: 2245
Presenter: D. Mariano

About Nabriva Therapeutics plc
Nabriva Therapeutics is a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections. Nabriva Therapeutics received U.S. Food and Drug Administration approval for XENLETA™ (lefamulin), the first systemic pleuromutilin antibiotic for community-acquired bacterial pneumonia (CABP). Nabriva Therapeutics is also developing CONTEPO™ (fosfomycin) for injection, a potential first-in-class epoxide antibiotic for complicated urinary tract infections (cUTI), including acute pyelonephritis. For more information, please visit www.nabriva.com.

About CONTEPO
CONTEPO (fosfomycin) for injection, (previously referred to as ZTI-01 and ZOLYD) is a novel, potentially first-in-class in the United States, intravenous investigational antibiotic with a broad spectrum of Gram-negative and Gram-positive activity, including activity against most contemporary multi-drug resistant (MDR) strains such as ESBL-producing Enterobacteriaceae. IV fosfomycin has been approved for a number of indications and utilized for over 45 years outside the U.S. to treat a variety of infections, including cUTIs and other serious bacterial infections. CONTEPO utilizes a new dosing approach, originally developed by Zavante (which Nabriva Therapeutics acquired), to optimize its pharmacokinetics and pharmacodynamics. Nabriva Therapeutics believes these attributes, along with the positive clinical experience worldwide, support CONTEPO as an early appropriate treatment for cUTIs, including acute pyelonephritis, suspected to be caused by MDR pathogens. An estimated 40 percent of cUTIs are suspected to be caused by MDR bacteria and limited treatment options are available in the U.S. for these patients.

About XENLETA
XENLETA (lefamulin) is a first-in-class semi-synthetic pleuromutilin antibiotic for systemic administration in humans discovered and developed by the Nabriva Therapeutics team. It is designed to inhibit the synthesis of bacterial protein, which is required for bacteria to grow. XENLETA’s binding occurs with high affinity, high specificity and at molecular sites that are different than other antibiotic classes. Efficacy of XENLETA was demonstrated in two multicenter, multinational, double-blind, double-dummy, non-inferiority trials assessing a total of 1,289 patients with CABP.  In these trials, XENLETA was compared with moxifloxacin and in one trial, moxifloxacin with and without linezolid. Patients who received XENLETA had similar rates of efficacy as those taking moxifloxacin alone or moxifloxacin plus linezolid. The most common adverse reactions associated with XENLETA include diarrhea, nausea, reactions at the injection site, elevated liver enzymes, and vomiting.

INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION

XENLETA is a pleuromutilin antibacterial indicated for the treatment of adults with community-acquired bacterial pneumonia (CABP) caused by the following susceptible microorganisms: Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae.

USAGE

To reduce the development of drug-resistant bacteria and maintain the effectiveness of XENLETA and other antibacterial drugs, XENLETA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

XENLETA is contraindicated in patients with known hypersensitivity to XENLETA or pleuromutilins.

XENLETA tablets are contraindicated for use with CYP3A4 substrates that prolong the QT interval.

WARNINGS AND PRECAUTIONS

XENLETA has the potential to prolong the QT interval. Avoid XENLETA in patients with known QT prolongation, ventricular arrhythmias, and patients receiving drugs that may prolong the QT interval.

Based on animal studies, XENLETA may cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception.

Clostridium difficile-associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including XENLETA, with severity ranging from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs.

ADVERSE REACTIONS

The most common adverse reactions (≥2%) for (a) XENLETA Injection are administration site reactions, hepatic enzyme elevation, nausea, hypokalemia, insomnia, and headache and (b) XENLETA Tablets are diarrhea, nausea, vomiting, and hepatic enzyme elevation.

USE IN SPECIFIC POPULATIONS

In patients with severe hepatic impairment, reduce the dosage of XENLETA Injection to 150 mg infused over 60 minutes every 24 hours. XENLETA Tablets are not recommended in patients with moderate or severe hepatic impairment due to insufficient information to provide dosing recommendations.

Avoid XENLETA Injection and Tablets with concomitant strong or moderate CYP3A or P-gp inducers. Monitor for reduced efficacy of XENLETA.

Avoid XENLETA Tablets with strong CYP3A or P-gp inhibitors.

Monitor for adverse reactions of sensitive CYP3A substrates administered with XENLETA Tablets.

XENLETA has not been studied in pregnant women. Verify pregnancy status in females prior to initiating XENLETA and advise females to use contraception during treatment and for 2 days after the final dose. Lactating women should pump and discard milk for the duration of treatment with XENLETA and for 2 days after the final dose.

To report SUSPECTED ADVERSE REACTIONS, or administration during pregnancy, contact Nabriva Therapeutics US, Inc. at 1-855-5NABRIVA or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see Full Prescribing Information for XENLETA.

Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for Nabriva Therapeutics, including but not limited to statements about launch and commercialization of XENLETA for the treatment of CABP, marketing exclusivity and patent protection for XENLETA, the development of CONTEPO for cUTI, the clinical utility of XENLETA for CABP and of CONTEPO for cUTI, plans for and timing of the review of regulatory filings for CONTEPO, efforts to bring XENLETA and CONTEPO to market, the market opportunity for and the potential market acceptance of XENLETA for CABP and CONTEPO for cUTI, the development of XENLETA and CONTEPO for additional indications, the development of additional formulations of XENLETA and CONTEPO, plans to pursue research and development of other product candidates, the sufficiency of Nabriva Therapeutics’ existing cash resources and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “likely,” “will,” “would,” “could,” “should,” “continue,” 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: Nabriva Therapeutics’ ability to successfully implement its commercialization plans for XENLETA and whether market demand for XENLETA is consistent with its expectations, Nabriva Therapeutics’ ability to build and maintain a sales force and prepare for commercial launch of XENLETA on the timeline expected, or at all, the content and timing of decisions made by the U.S. Food and Drug Administration and other regulatory authorities, the uncertainties inherent in the initiation and conduct of clinical trials, availability and timing of data from clinical trials, whether results of early clinical trials or studies in different disease indications will be indicative of the results of ongoing or future trials, uncertainties associated with regulatory review of clinical trials and applications for marketing approvals, the availability or commercial potential of CONTEPO for the treatment of cUTI or of XENLETA for the treatment of CABP, the ability to retain and hire key personnel, the sufficiency of cash resources and need for additional financing and such other important factors as are set forth in Nabriva Therapeutics’ annual and quarterly reports and other filings on file with the U.S. Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent Nabriva Therapeutics’ views as of the date of this press release. Nabriva Therapeutics anticipates that subsequent events and developments will cause its views to change. However, while Nabriva Therapeutics may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Nabriva Therapeutics’ views as of any date subsequent to the date of this press release.

CONTACTS:

For Investors
 Gary Sender Nabriva Therapeutics plc
 ir@nabriva.com 

For Media
 Mike Beyer Sam Brown Inc.
 mikebeyer@sambrown.com
312-961-2502

 

Source: Nabriva Therapeutics US, Inc