Nabriva Therapeutics to Present Data at ASM/ESCMID Conference Demonstrating Utility of Xenleta™ (lefamulin) for Patients with Community-Acquired Bacterial Pneumonia (CABP)

DUBLIN, Ireland, Sept. 05, 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, today announced that it will present data at the ASM/ESCMID ConferenceSeptember 3-6, 2019 in Boston, MA. This meeting is co-sponsored by the American Society for Microbiology and the European Society for Clinical Microbiology and Infectious Diseases, and addresses drug development to meet the challenge of antimicrobial resistance. 

“We are committed to providing patients and their treating physicians, novel anti-infective treatment options that are both well-tolerated and effective and help to address the growing global threat of antimicrobial resistance,” said Jennifer Schranz MD, Chief Medical Officer of Nabriva Therapeutics.  “At ASM/ESCMID, we will present data from the lefamulin clinical program that further support the safety and efficacy of lefamulin for the treatment of adult patients with CABP.” 

Highlights of the data to be presented at ASM/ESCMID Conference include:

Thursday, September 5^th
Poster Presentation Session
Time: 4:30 p.m. – 6:30 p.m.       

• Poster T-18 – Pharmacokinetic-Pharmacodynamic (PK-PD) Analyses for Efficacy Based on Data from Lefamulin-Treated Patients Enrolled in Phase 3 Studies for Community-Acquired Bacterial Pneumonia (CABP).
  In a study evaluating PK‐PD relationships for efficacy using data from lefamulin‐treated patients with CABP from two phase 3 trials, efficacy results of these analyses provide support for the lefamulin dosing regimens of 150 mg IV q12h and 600 mg PO q12h for the treatment of adult patients with CABP.     

• Poster T-19 – Pharmacokinetic-Pharmacodynamic Target Attainment Analyses to Support Lefamulin Dose Justification and Susceptibility Breakpoint Determinations for Patients with Community-Acquired Bacterial Pneumonia
  A population PK model was further refined utilizing PK data collected in phase 3 from CABP patients, nonclinical PK-PD targets for efficacy and in vitro surveillance data with Monte Carlo simulation to perform PK-PD target attainment analyses for dose justification.  Results provide support for selection of lefamulin 150 mg IV q12h and 600 mg PO q 12 h in patients for treatment of CABP with or without regard to food.       

• Poster T-20 – Pharmacokinetic-Pharmacodynamic (PK-PD) Analyses for Alanine Aminotransferase (ALT) Using Phase 2 and 3 Data from Lefamulin-Treated Patients
  PK‐PD relationships for ALT were evaluated using phase 2 and 3 data from lefamulin‐treated patients. While a covariate‐adjusted relationship between increased ALT and increased lefamulin AUC was found, model‐predicted ALT elevation endpoints across fixed lefamulin AUC values, or among simulated patients after administration of lefamulin IV or PO dosing regimens relative to observed patients, were minimal.

• Poster T-74 –Lefamulin (LEF) Activity against Gram-Positive Pathogens Collected in the 2017 Global SENTRY Surveillance Program
  The objective of this study was to evaluate the in vitro activity of lefamulin and comparators against a contemporary global set of Gram-positive pathogens. As part of the 2017 global SENTRY Antimicrobial Surveillance Program, 4337 unique isolates (34 countries, 98 sites) were collected from patients with community-acquired respiratory tract infections (40.0%), hospitalized patients with pneumonia (13.6%), bloodstream infections (23.2%), skin and soft tissue infections (18.7%), and other infections (4.5%). Lefamulin showed potent antibacterial activity against all tested pathogens, and its activity was unaffected by resistance to other antibiotic classes including macrolides, fluoroquinolones or beta-lactam antibiotics. 

  The abstracts can be accessed through the ASM/ESCMID Conference website.  Following the meeting, the posters will be available on the Nabriva website.

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^TM (fosfomycin) for injection, a potential first-in-class epoxide antibiotic for complicated urinary tract infections (cUTI), including acute pyelonephritis. For more information, please visit https://www.nabriva.com.

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, 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 InvestorsGary SenderNabriva Therapeutics plc
ir@nabriva.com 

For MediaMike BeyerSam Brown Inc.
mikebeyer@sambrown.com
312-961-2502

Source: Nabriva Therapeutics US, Inc