VIENNA, Austria and KING OF PRUSSIA, Pa., Oct. 20, 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, today announced presentations for lefamulin, the company’s advanced clinical-stage product candidate, at the upcoming IDWeek conference, which will take place in New Orleans, LA, October 26-30, 2016.
Lefamulin is a novel semi-synthetic antibiotic Nabriva is developing to be the first pleuromutilin antibiotic available for systemic administration in humans and is the first new class of antibiotic to have reached late stage clinical development for Community Acquired Bacterial Pneumonia (CABP) in over a decade. Nabriva has initiated two global, registrational Phase 3 clinical trials investigating lefamulin treatment in patients with moderate-to-severe CABP.
“Our presentations at IDWeek support the pharmacokinetic-pharmacodynamic rationale for selection of the IV and oral dosing in our current Phase 3 program for lefamulin for the treatment of CABP,” said Steve Gelone, Pharm.D., Chief Development Officer of Nabriva. “We are looking forward to further discussions at the conference and continuing to provide data that differentiates the first systemic pleuromutilin product candidate for the clinical and research communities.”
The poster presentations are:
Title: Population Pharmacokinetic (PPK) Analysis for Lefamulin Using Phase 1 Data and Assessment of Optimal PK Sampling Strategies (OSS) for a Phase 3 Community-Acquired Bacterial Pneumonia (CABP) Study (Poster No. 1944)
Session Title: Antimicrobial Pharmacokinetics and Pharmacodynamics
Session Timing: Saturday, October 29, 2016
Location: New Orleans Ernest N. Morial Convention Center, Poster Hall
Authors: Li Zhang, M.D., Ph.D.1, Sujata Bhavnani, Pharm.D., M.S.1, Paul G. Ambrose, Pharm.D., FIDSA1, Wolfgang W. Wicha, M.S.2, Steve Gelone, Pharm.D.3 and Christopher M. Rubino, Pharm.D.1; (1) Institute for Clinical Pharmacodynamics, Schenectady, NY, (2) Nabriva Therapeutics AG, Vienna, Austria, (3) Nabriva Therapeutics AG, King of Prussia, PA
Title: Pharmacokinetic-Pharmacodynamic (PK-PD) Target Attainment Analyses to Support Oral Lefamulin Dose Selection in the Treatment of Patients with Community-Acquired Bacterial Pneumonia (CABP) (Poster No. 1976)
Session Title: Antimicrobial Pharmacokinetics and Pharmacodynamics
Session Timing: Saturday, October 29, 2016
Location: New Orleans Ernest N. Morial Convention Center, Poster Hall
Authors: Sujata Bhavnani, Pharm.D., M.S.1, Li Zhang, M.D., Ph.D.1, Christopher M. Rubino, Pharm.D.1, Justin C. Bader, Pharm.D., MBA1, Wolfgang W. Wicha, M.S.2, Steve Gelone, Pharm.D.3 and Paul G. Ambrose, Pharm.D., FIDSA1; (1) Institute for Clinical Pharmacodynamics, Schenectady, NY, (2) Nabriva Therapeutics AG, Vienna, Austria, (3) Nabriva Therapeutics AG, King of Prussia, PA
IDWeek 2016TM is the combined annual meeting of the Infectious Diseases Society of America (IDSA), the Society for Healthcare Epidemiology of America (SHEA), the HIV Medicine Association (HIVMA), and the Pediatric Infectious Diseases Society (PIDS).
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 community-acquired bacterial pneumonia (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.
CONTACT: CONTACT: Will Sargent Nabriva Therapeutics AG William.Sargent@nabriva.com
