VIENNA, Austria and KING OF PRUSSIA, Pa., May 16, 2016 (GLOBE NEWSWIRE) -- Nabriva Therapeutics AG (NASDAQ:NBRV), a clinical stage biopharmaceutical company engaged in the research and development of novel anti-infective agents to treat serious infections, with a focus on the pleuromutilin class of antibiotics, announced today that research findings for the Company’s advanced clinical-stage product candidate, lefamulin, will be presented at next month’s American Society of Microbiology (ASM) Microbe 2016 Conference, taking place in Boston, MA, on June 16-20, 2016.
Lefamulin is a novel semi-synthetic antibiotic that we are developing to be the first pleuromutilin antibiotic available for systemic administration in humans and is the first new class of antibiotic to reach late stage clinical development for community-acquired bacterial pneumonia (CABP) in over a decade. Lefamulin has potent in vitro activity against gram-positive, gram-negative and atypical bacteria that commonly cause CABP, including multi-drug resistant strains. We have initiated two global, registrational Phase 3 clinical trials (LEAP 1 and LEAP 2) with lefamulin for the treatment of moderate to severe CABP patients, with top-line data expected in the second half of 2017.
ASM Microbe 2016 Poster Presentation Details:
|Title:||In Vitro Activity of Lefamulin Against Macrolide-Susceptible (MSMP) and Macrolide-Resistant Mycoplasma pneumoniae (MRMP) from the United States, Europe, and China|
|Authors:||K.B. Waites1, D.M. Crabb1, L.B. Duffy1, Y. Liu2, and S. Paukner3 1Department of Pathology, University of Alabama at Birmingham, Birmingham, AL USA; 2Institute of Antibiotics, Huashan Hospital, Institute of Biomedical Sciences, Fudan University, Shanghai, China; 3Nabriva Therapeutics AG, Vienna Austria|
|Date & Time:||Sunday June 19, 2016, 12:30 PM - 2:30 PM Eastern Time|
|Session:||Session 307 - Macrolides, Oxazolidinones and Related Compounds II|
|Location:||Boston Convention and Exhibition Center, Exhibit and Poster Hall, Halls A and B|
The poster abstract is now available on the ASM Microbe 2016 website.
“Macrolide resistance in Mycoplasma pneumoniae is a growing concern globally, particularly in the United States, where macrolides play a significant role in the treatment of CABP in both adults and children,” Steve Gelone, Pharm.D., Chief Development Officer of Nabriva commented. “We are pleased to announce the presentation of these data at the ASM Microbe meeting next month.”
About Nabriva Therapeutics AG
Nabriva Therapeutics is a clinical stage biopharmaceutical company engaged in the research and development of novel anti-infective agents to treat serious bacterial infections, with a focus on the pleuromutilin class of antibiotics. Nabriva's medicinal chemistry expertise has enabled targeted discovery of novel pleuromutilins, including both intravenous and oral formulations of its lead product candidate. Nabriva's lead pleuromutilin product candidate, lefamulin, is being developed to be the first systemically available pleuromutilin for human use and is the first new class of antibiotic to reach late stage clinical development for CABP in over a decade. Nabriva believes lefamulin is well positioned for use as a first-line empiric monotherapy for the treatment of moderate to severe CABP due to its novel mechanism of action, targeted spectrum of activity, resistance profile, achievement of substantial drug concentration in lung tissue and fluid, oral and IV formulations and favorable tolerability profile. Nabriva also intends to further pursue the development of lefamulin for additional indications, including the treatment of acute bacterial skin and skin structure infections, and is developing a formulation of lefamulin appropriate for pediatric use.
Nabriva owns exclusive, worldwide rights to lefamulin, which is protected by composition of matter patents issued in the United States, Europe and Japan.
Forward Looking Statements
Any statements in this press release about future expectations, plans and prospects for Nabriva, including but not limited to statements about the development of Nabriva’s product candidates, such as plans for the design, conduct and timelines of Phase 3 clinical trials of lefamulin for CABP, the clinical utility of lefamulin for CABP and Nabriva’s plans for filing of regulatory approvals and efforts to bring lefamulin to market, the development of lefamulin for additional indications, the development of additional formulations of lefamulin, plans to pursue research and development of other product candidates 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 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 trials 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 product candidates including lefamulin for use as a first-line empiric monotherapy for the treatment of moderate to severe CABP, the sufficiency of cash resources and need for additional financing and such other important factors as are set forth under the caption "Risk Factors" in Nabriva’s annual report on Form 20-F as filed with the United States Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent Nabriva’s views as of the date of this release. Nabriva anticipates that subsequent events and developments will cause its views to change. However, while Nabriva 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’s views as of any date subsequent to the date of this release.
Nabriva Therapeutics AG
Source: Nabriva Therapeutics US