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

DUBLIN, Ireland, June 21, 2019 (GLOBE NEWSWIRE) — Nabriva Therapeutics plc (NASDAQ: NBRV), a clinical-stage biopharmaceutical company engaged in the development of innovative anti-infective agents to treat serious infections, today announced that it will present data at ASM Microbe 2019 to be held June 20 – 24 in San Francisco, CA.

“At Nabriva, we are committed to the fight against the growing threat of antimicrobial resistance in CABP and cUTIs and bringing novel anti-infective agents to patients in need. The ASM delegation is an important partner in this struggle,” said Jennifer Schranz, M.D., Chief Medical Officer of Nabriva Therapeutics.  “At ASM Microbe, we will present additional data from our phase 3 lefamulin and CONTEPO clinical studies that further support efficacy by pathogen for CABP and cUTI, respectively.” 

Highlights of the data to be presented at ASM Microbe 2019 include:

Friday June 21st

Session: P404 – CIV01 – Clinical Studies of Adult Infectious Diseases: Urinary Tract Infections
Time: 11:00 a.m. – 12:00 p.m. & 4:00 p.m. – 5:00 p.m.

CIV-148 – Fosfomycin for Injection (FOS) Versus (vs) Piperacillin-Tazobactam (PIP-TAZ) for Treating Complicated Urinary Tract Infections (cUTI) and Acute Pyelonephritis (AP): Further Analyses of the ZEUS Study

Saturday June 22^nd

Session: P508 – AAR02 – Antimicrobial Agents: Mechanisms of Resistance in Gram-Negative Bacteria
Time: 11:00 a.m. – 12:00 p.m. & 4:00 p.m. – 5:00 p.m.

AAR-666 – In Vitro and In Vivo Effects of Fosfomycin Resistant Mutants on Bacterial Growth and Efficacy in the Murine UTI Model

Session: P515 – AAR09 – Pharmacological Studies of Novel Investigational Agents (Phase 2/3)
Time: 11:00 a.m. – 12:00 p.m. & 4:00 p.m. – 5:00 p.m.

AAR-786 – Lefamulin Activity against Respiratory Tract Pathogens Collected in the 2017 Global SENTRY Surveillance Program

AAR-785 – Lefamulin Activity against Bacterial Pathogens Commonly Associated with Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Collected in the 2017 Global SENTRY Surveillance Program

Sunday June 23rd

Session: P553 – CIV01 – Clinical Studies of Adult Infectious Diseases: Pneumonia in Children and Adults
Time: 11:00 a.m. – 1:00 p.m.

CIV-177 – Efficacy of Lefamulin (LEF) versus Moxifloxacin (MOX) by Pathogen in Adults with Community-Acquired Bacterial Pneumonia (CABP): Pooled Results from the LEAP 1 and LEAP 2 Phase 3 Clinical Trials

The abstracts can be accessed through the ASM Microbe 2019 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 Nabriva Therapeutics’ plans for further interactions with the FDA; 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:  Nabriva Therapeutics’ ability to resolve the matters set forth in the Complete Response Letter it received from the FDA in connection with its NDA for CONTEPO (fosfomycin) for injection; Nabriva Therapeutics’ reliance on third-party manufacturers to manufacture the clinical and commercial supply of its product candidates and the ability of such third parties to comply with applicable regulatory requirements; 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