DUBLIN, Ireland, Sept. 28, 2018 — Nabriva Therapeutics Plc (NASDAQ:NBRV), a clinical-stage biopharmaceutical company engaged in the research and development of innovative anti-infective agents to treat serious infections, today announced that it will present data at Infectious Diseases Society of America (IDSA) IDWeek™ 2018 taking place in San Francisco, CA from October 3-7, 2018.
At the meeting, four presentations, including a late-breaker, oral platform presentation of the Phase 3, pivotal LEAP 2 study, demonstrating non-inferiority of 5 days of oral lefamulin to 7 days of oral moxifloxacin, will feature both clinical and in vitro microbiological data that support lefamulin as a potential IV and oral treatment for CABP. Additionally, one poster presentation will feature CONTEPO, a novel, potentially first-in-class, intravenous antibiotic in the United States. This poster will focus on clinical and microbiological response at test of cure in secondary efficacy populations from the pivotal Phase 2/3 clinical trial (ZEUS™) for the treatment of cUTIs, including acute pyelonephritis (AP), which demonstrated non-inferiority to piperacillin/tazobactam in patients with cUTI, including AP.
“These data are part of a growing body of evidence supporting lefamulin and CONTEPO as promising first-in-class antibiotic treatments in the United States for key pathogens, including multi-drug resistant strains, for CABP and cUTI, respectively. To address the current rise of antibiotic resistance it is imperative that new classes of antibiotics with unique mechanisms of action continue to be developed to provide health care providers treatment options for patients with serious infections,” said Jennifer Schranz, M.D., Chief Medical Officer of Nabriva Therapeutics. “Following the positive results from our Phase 3 clinical trials of lefamulin and our Phase 2/3 clinical trial of CONTEPO, we believe that both lefamulin and CONTEPO have the potential to change the treatment paradigm of CABP and cUTIs, respectively, and we are on track to submit New Drug Applications (NDAs) to the U.S. Food and Drug Administration (FDA) in the fourth quarter of this year.”
Highlights of the data to be presented at ID Week include:
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Thursday, October 4 at 11:20 AM PT Presenter: Jennifer Schranz, MD Session: 48. Late Breaker Oral Abstracts: HIV and Antibiotic Trials Title: Oral Lefamulin Is Safe and Effective in the Treatment of Adults with Community-Acquired Bacterial Pneumonia (CABP): Results of Lefamulin Evaluation Against Pneumonia (LEAP 2) Study
Friday, October 5 at 12:30-1:45 PM PT Presenter: Dr. Robert Flamm, PhD Poster Session: 144. Novel Agents, #1365 Title: In Vitro Activity of Lefamulin (LEF) Against Bacterial Pathogens Causing Community-Acquired Bacterial Pneumonia (CABP): SENTRY Surveillance 2016 Results from Asia-Pacific (APAC) and Latin America (LA)
Presenter: Dr. Helio Sader, MD, PhD Poster Session: 144. Novel Agents, #1353 Title: In Vitro Activity of Lefamulin (LEF) against Bacterial Pathogens Commonly Causing Community-Acquired Bacterial Pneumonia (CABP): 2016 SENTRY Data from the United States
Saturday, October 6 at 12:30-1:45 PM PT Presenter: Matthew Helgeson, PharmD Poster Session: 250. Treatment of AMR Infections, #2386 Title: Efficacy of Lefamulin (LEF) Versus (vs) Moxifloxacin (MOX) Against Common Pathogens in Adults with Community-Acquired Bacterial Pneumonia (CABP): Results from the Phase 3 Lefamulin Evaluation Against Pneumonia (LEAP 1) Study
Friday, October 5 at 12:30-1:45 PM PT Presenter: Paul B. Eckburg, MD Poster Session: 144. Novel Agents, #1367 Title: Clinical Cure in Secondary Efficacy Populations in Patients with Complicated Urinary Tract Infection Treated with ZTI-01 (fosfomycin for injection): Findings from the ZEUS Trial
About Nabriva Therapeutics plc Nabriva Therapeutics is a clinical-stage biopharmaceutical company engaged in the research and development of innovative anti-infective agents to treat serious infections. Nabriva Therapeutics has two product candidates that are in late stage development: lefamulin, under development to potentially be the first pleuromutilin antibiotic available for systemic administration in humans, and CONTEPO, a potential first-in-class in the United States, hospital-based intravenous, or IV, antibiotic. Nabriva Therapeutics is developing both IV and oral formulations of lefamulin for the treatment of community-acquired bacterial pneumonia, or CABP. Nabriva Therapeutics is developing CONTEPO IV for complicated urinary tract infections, or cUTI. Nabriva Therapeutics may potentially develop lefamulin and CONTEPO for additional indications. 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 future expectations, prospects, estimates and other matters that are dependent upon future events or developments, including statements related to Nabriva Therapeutics’ expectations with respect to the potential financial impact and benefits of the acquisition of Zavante Therapeutics Inc., including Nabriva Therapeutics’ expectations with respect potential advantages of CONTEPO as well as any statements with respect to the development of Nabriva Therapeutics’ product candidates, such as the future development or commercialization of lefamulin and CONTEPO, conduct and timelines of clinical trials, the clinical utility of lefamulin for CABP and of CONTEPO for cUTI and plans for filing of regulatory approvals and 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 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, 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 realize the anticipated benefits, synergies and growth prospects of the acquisition of Zavante Therapeutics Inc., 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 moderate to severe CABP and CONTEPO for the treatment of cUTI, whether regulatory or commercial milestones are achieved, Nabriva Therapeutics’ ability to successfully integrate Zavante Therapeutics’ business into its business, Nabriva Therapeutics’ ability to retain and hire key personnel, the risk that disruption resulting from the acquisition may adversely affect Nabriva Therapeutics’ business and business relationships, including with employees and suppliers, 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.
FOR INVESTORS Dave Garrett Nabriva Therapeutics plc [email protected] 610-816-6657
FOR MEDIA Benjamin Navon Pure Communications [email protected] 617-337-4166