Nabriva Therapeutics to Present Data at ECCMID Demonstrating Potential of Lefamulin for Patients with Community-acquired Bacterial Pneumonia (CABP) and CONTEPO™ (fosfomycin for injection) to Treat Complicated Urinary Tract Infections (cUTIs)

New data continue to support lefamulin and CONTEPO as potential first-in-class antibiotics in the United States that target the most common causative pathogens of CABP and cUTI, including multi-drug resistant (MDR) strains

DUBLIN, Ireland, April 11, 2019 (GLOBE NEWSWIRE) — Nabriva Therapeutics plc (NASDAQ: NBRV), a biopharmaceutical company engaged in the development of innovative anti-infective agents to treat serious infections, today announced that it will present data at the 29^th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) taking place in Amsterdam, the Netherlands from April 13-16, 2019.

“Nabriva Therapeutics is committed to advancing the health of patients with serious bacterial infections by developing innovative anti-infective agents that address the growing global threat of antimicrobial resistance,” said Jennifer Schranz, M.D., Chief Medical Officer of Nabriva Therapeutics.  “These data presented at ECCMID illustrate Nabriva’s leadership in advancing scientific knowledge related to the treatment and health outcomes in patients with CABP, the safety profile of short course, oral therapy with lefamulin for CABP and in vitro susceptibility testing and microbiologic surveillance for lefamulin and CONTEPO.”

Highlights of the data to be presented at ECCMID include:

Saturday, April 13 at 3:30 – 4:30 p.m. CET

Poster #P0478
Presenter: Vikas Gupta Pharm.D., BCPS
Session: Clinical aspects of community-acquired pneumonia and respiratory tract infection
Title: Microbiology and outcomes among patients hospitalized with Community Onset Pneumonia: A multicenter retrospective cohort study

Poster #P0479
Presenter: Ying Tabak PhD
Session: Clinical aspects of community-acquired pneumonia and respiratory tract infection
Title: Culture-positive patients hospitalised with community-onset pneumonia have worse outcomes than those with negative or no culture: a multi-centre retrospective cohort study

Monday, April 15 at 12:30-1:30 p.m. CET

Poster #P1733
Presenter: Elizabeth B. Hirsch, PharmD
Session: Diverse methodologies for MIC testing in Gram-negatives
Title: Lack of agreement between fosfomycin susceptibility testing methods against clinical Pseudomonas aeruginosa isolates

Monday, April 15 at 1:30 – 2:30 p.m. CET

Poster #P1823
Presenter: Helio S. Sader, MD, PhD
Session: In vitro activity of investigational antibacterial agents
Title: Antimicrobial activity of lefamulin against a large longitudinal collection of clinical bacterial isolates collected worldwide: results from the SENTRY antimicrobial surveillance program

Poster #P1828
Presenter: Susanne Paukner, Ph.D.
Session: In vitro activity of investigational antibacterial agents
Title: In vitro activity of lefamulin against isolates commonly causing community-acquired bacterial pneumonia collected during the SENTRY surveillance programme 2017 in Europe

Poster #P1945
Presenter: Nikolas J. Onufrak, Pharm.D
Session: Recent research on the pharmacokinetics and safety of antibacterial agents
Title: Population pharmacokinetic analysis for lefamulin using data from healthy volunteers and infected patients

Poster #P1946
Presenter: Sujata M. Bhavnani, Pharm.D., M.S.Session: Recent research on the pharmacokinetics and safety of antibacterial agents
Title: Pharmacokinetic-Pharmacodynamic (PK-PD) Target Attainment Analyses to Support Lefamulin Dose Justification and Susceptibility Breakpoints for Patients with Community-Acquired Bacterial Pneumonia (CABP)

Tuesday, April 16 at 11:00 a.m. – 12:00 p.m. CET 

Presenter: Jennifer Schranz, MD
Mini-oral ePoster Session OE208 – Defining exposure, efficacy and safety of new antimicrobial agents
Title: Oral lefamulin demonstrates favorable safety and tolerability in adults with community acquired bacterial pneumonia in the phase III lefamulin evaluation against pneumonia (LEAP 2) study

The abstracts can be accessed through the ECCMID 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 development of innovative anti-infective agents to treat serious infections. Nabriva Therapeutics has two product candidates that are in late stage development: lefamulin, potentially the first systemic pleuromutilin antibiotic for CABP and CONTEPO (fosfomycin for injection), a potential first-in-class epoxide antibiotic in the United States for complicated urinary tract infections (cUTIs) including acute pyelonephritis (AP). 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 the development of Nabriva Therapeutics’ product candidates, such as the future development or commercialization of lefamulin and CONTEPO, the clinical utility of lefamulin for CABP and of CONTEPO for cUTI, plans for and timing of the review of regulatory filings, efforts to bring lefamulin and CONTEPO to market, the market opportunity for and the potential market acceptance of lefamulin for CABP and CONTEPO for cUTI, the potential benefits under its license agreement with Sinovant Sciences, the development of lefamulin and CONTEPO for additional indications, the development of additional formulations of lefamulin and CONTEPO, plans to pursue research and development of other product candidates, its ability to achieve any of the specified regulatory or performance milestones under its loan agreement with Hercules Capital, 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:  the content and timing of decisions made by the U.S. Food and Drug Administration and other regulatory authorities, Nabriva Therapeutics’ ability to realize the anticipated benefits, synergies and growth prospects of its acquisition of Zavante Therapeutics, 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, whether results of ZEUS will be indicative of results for any ongoing or future clinical trials and studies of CONTEPO, uncertainties associated with regulatory review of clinical trials and applications for marketing approvals, the availability or commercial potential of product candidates including lefamulin for use as a first-line empiric monotherapy for the treatment of CABP and CONTEPO for the treatment of cUTI, 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 InvestorsDave GarrettNabriva Therapeutics plc
david.garrett@nabriva.com
610-816-6657

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

Source: Nabriva Therapeutics US, Inc