News &amp; Publications

Pharmacokinetic-Pharmacodynamic (PK-PD) Analyses for Efficacy Based on Data From Lefamulin-Treated Patients Enrolled in Phase 3 Studies for Community-Acquired Bacterial Pneumonia (CABP)

Pharmacokinetic-Pharmacodynamic (PK-PD) Analyses for Alanine Aminotransferase (ALT) Using Phase 2 and 3 Data From Lefamulin-Treated Patients

Lefamulin Activity Against Gram-Positive PathogensCollected in the 2017 Global SENTRY Antimicrobial Surveillance Program

American Society For Microbiology (ASM) MICROBE

ASM MICROBE 2019

Lefamulin Activity Against Bacterial Pathogens Commonly Associated With Acute Bacterial Skin and Skin Structure Infections (ABSSSIs) Collected in the 2017 Global SENTRY Antimicrobial Surveillance Program

(PDF, 595KB)

Lefamulin Activity Against Respiratory Tract Pathogens Collected in the 2017 Global SENTRY Antimicrobial Surveillance Program

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

(PDF, 392KB)

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

ASM MICROBE 2018

(PDF, 468KB)

Lefamulin Is Non-inferior to Moxifloxacin in Adults with Community-Acquired Bacterial Pneumonia (CABP): The Phase 3 Lefamulin Evaluation Against Pneumonia (LEAP 1) Study

(PDF, 386KB)

Lefamulin Demonstrates Favorable Safety and Tolerability in Adults with Community-Acquired Bacterial Pneumonia (CABP) in the Phase 3 Lefamulin Evaluation Against Pneumonia (LEAP 1) Study

(PDF, 234KB)

Correlation of High-Risk Antibiotic Use and Hospital-Associated C. difficile Infections: Data From 195 US Hospitals

(PDF, 299KB)

A Multicenter Evaluation of Pathogen Distribution in Patients Admitted With Microbiologically-Confirmed Community-Acquired Bacterial Pneumonia (CABP) in the

(PDF, 399KB)

Molecular Characterization of Resistance Mechanisms Associated With Pleuromutilins Among Gram-Positive Clinical Isolates From the Worldwide SENTRY Surveillance Studies for Lefamulin

(PDF, 400KB)

In Vitro Activity of Lefamulin Against Bacterial Pathogens Commonly Causing Acute Bacterial Skin and Skin Structure Infections (ABSSSI) and Bloodstream Infections (BSI): Global SENTRY Surveillance 2016

(PDF, 849KB)

In Vitro Activity of Lefamulin Against Bacterial Pathogens Commonly Causing Community-Acquired Respiratory Tract Infections (CARTI) – Global SENTRY Surveillance 2016

(PDF, 4.40MB)

Tissue Distribution of [14C]-Lefamulin Into the Urogenital Tract in Rats

ASM MICROBE 2017

Nabriva presented four poster presentations on lefamulin’s in vitro activity against key pathogens commonly causing respiratory tract infections and ten Scientific papers on Fosfomcycin at ASM Microbe in New Orleans, LA.

(PDF, 131KB)

Fosfomycin Activity When Tested Against Gram-positive and Gram-negative US Isolates Collected by the SENTRY Antimicrobial Surveillance Program (R. K. Flamm, et al, ASM Microbe, June 3, 2017)

(PDF, 213KB)

Fosfomycin In Vitro Activity Against Bacteria with Various Mechanisms of Resistance to other Antibacterials from US Hospitals (D. Shortridge, et al, ASM Microbe, June 3, 2017)

(PDF, 482KB)

Fosfomycin (FOS) for Injection: Activity Against Carbapenem-resistant and Ceftazidime-avibactam Resistant Enterobacteriaceae (CRE) Clinical Isolates with Diverse Resistance Mechanisms (C. Clancy, et al, ASM Microbe, June 3, 2017)

(PDF, 27KB)

Population Pharmacokinetic (PK) Analysis of ZTI-01 (Fosfomycin for Injection) Using Phase 1 Data for ZTI-01 and Evaluation of a Phase 2/3 Sparse PK Sampling Strategy (M. Trang, et al, ASM Microbe, June 3, 2017)

(PDF, 178KB)

Pharmacokinetics-Pharmacodynamics (PK-PD) Target Attainment Analyses to Support ZTI-01 (Fosfomycin for Injection) Dose Selection for Patients with Complicated Urinary Tract Infections (cUTI) (S. M. Bhavnani, et al, ASM Microbe, June 3, 2017)

(PDF, 123KB)

Pharmacokinetics, Safety, and Tolerability of Single Dose Intravenous and Oral Fosfomycin in Healthy Volunteers (E. Wenzler, et al, ASM Microbe, June 3, 2017)

(PDF, 131KB)

In Vivo Pharmacodynamics of ZTI-01 (Fosfomycin for Injection) in the Neutropenic Murine Thigh Infection Model Against ESBL-positive E. coli (EC), Carbapenem-resistant (CR) K. pneumoniae (KPN), and P. aeruginosa (PSA) (A. J. Lepak, et al, ASM Microbe, June 3, 2017)

(PDF, 68KB)

Evaluation of the Antimicrobial Activity of Fosfomycin When Combined with Selected Antimicrobial Agents and Tested Against Bacterial Isolates Using Checkerboard Methods (P. R. Rhomberg, et al, ASM Microbe, June 3, 2017)

(PDF, 131KB)

Correlation of Reference Agar Dilution MIC Values and Kirby-Bauer Disk Diffusion Testing for Fosfomycin Against Gram-positive and Gram-negative Bacteria (R. K. Flamm, et al, ASM Microbe, June 3, 2017)

(PDF, 152KB)

Time Kill Analyses of Concerning Gram-negative Bacteria (GNB) by Fosfomycin Alone and in Combination with Select Antimicrobial Agents (R. K. Flamm, et al, ASM Microbe, June 2, 2017)

(PDF, 343KB)

In Vitro Activity of Lefamulin against a Collection of Respiratory Pathogens from Pediatric Patients In US (SENTRY Surveillance 2015)

(PDF, 343KB)

In Vitro Activity of Lefamulin against Bacterial Pathogens Collected from Patients with Community-Acquired Bacterial Pneumonia (CABP) – SENTRY 2015 US Data

(PDF, 273KB)

In Vitro Antibacterial Activity of Lefamulin against S. aureus Collected from Hospitalized Patients with Bacterial Pneumonia in US

(PDF, 273KB)

In Vitro Activity of Lefamulin against Bacterial Pathogens Commonly Causing Pneumonia Collected from Patients in Asia (2015)

American Thoracic Society (ATS)

ATS 2022

(PDF, 515KB)

Lefamulin Efficacy and Safety in Adults With Community-Acquired Bacterial Pneumonia (CABP): Pooled Analysis of The Lefamulin Evaluation Against Pneumonia (LEAP) 1 and LEAP 2 Trials in Patients With Asthma or Chronic Obstructive Lung Disease (COPD)

CHEST

CHEST 2022

(PDF, 130KB)

LEFAMULIN EFFICACY IN ADULTS WITH COMMUNITY-ACQUIRED BACTERIAL PNEUMONIA (CABP) IS UNAFFECTED BY OBESITY: POOLED ANALYSIS OF THE LEFAMULIN PHASE-3 CLINICAL TRIAL PROGRAM

CHEST 2021

(PDF, 55KB)

LEFAMULIN EFFICACY AND SAFETY IN ADULTS WITH COMMUNITYACQUIRED BACTERIAL PNEUMONIA: POOLED ANALYSIS OF THE LEFAMULIN EVALUATION AGAINST PNEUMONIA (LEAP) 1 AND LEAP 2 TRIALS IN PATIENTS WITH MULTILOBAR OR UNILOBAR PNEUMONIA

CHEST 2020

(PDF, 580KB)

Lefamulin Efficacy and Safety in Adults With Community-Acquired Bacterial Pneumonia: Pooled Analysis of the Lefamulin Evaluation Against Pneumonia (LEAP) 1 and LEAP 2 Trials by Age Group, Including in Patients Aged ≥85 Years

CHEST 2019

Efficacy and Safety of Lefamulin Versus Moxifloxacin for Atypical Respiratory Pathogens in Adults With Community-Acquired Bacterial Pneumonia: Pooled Results From the Lefamulin Evaluation Against Pneumonia (LEAP) 1 and LEAP 2 Double-Blind Noninferiority Phase 3 Clinical Trials

Efficacy of Lefamulin Versus Moxifloxacin in Adults With Community-Acquired Bacterial Pneumonia: Results of the Lefamulin Evaluation Against Pneumonia (LEAP) 1 and LEAP 2 Double-Blind Noninferiority Phase 3 Clinical Trials

Safety and Tolerability of Lefamulin Versus Moxifloxacin in Adults With Community-Acquired Bacterial Pneumonia: Results of the Lefamulin Evaluation Against Pneumonia (LEAP) 1 and LEAP 2 Double-Blind Noninferiority Phase 3 Clinical Trials

European Congress Of Clinical Microbiology & Infectious Diseases (ECCMID)

ECCMID 2022

Nabriva presented 4 posters at ECCMID 2022 that support lefamulin’s in vitro activity against S. aureus globally and a collection of CAP pathogens across Europe, as well as lefamulin susceptibility testing methods.

(PDF, 1474KB)

Lefamulin Activity against a Contemporary Global Collection of Staphylococcus aureus (SENTRY 2020–2021)

(PDF, 1200KB)

Lefamulin Activity against Bacterial Pathogens Typically Causing Pneumonia Collected from European Medical Centers in 2020 and 2021

(PDF, 2234KB)

Evaluation of the Oxoid Lefamulin 20 μg Antimicrobial Susceptibility Testing (AST) Disc Against the Predicate Lefamulin 20 μg AST Disc

(PDF, 367KB)

Comparison of Lefamulin MIC Test Strip (MTS) to Broth Microdilution MIC for Streptococcus spp., S. aureus, M. catarrhalis, and Haemophilus spp.

ECCMID 2021

Nabriva presented one oral presentation and 2 e-posters at ECCMID 2021 that supports lefamulin’s in vitro activity regarding pathogens that commonly cause community-acquired bacterial pneumonia (EU isolates), Cystic Fibrosis (isolates from non-CF pediatric patients), and Pleuromutilin resistance mechanisms.

(PDF, 504KB)

In Vitro Activity of Lefamulin against Staphylococcus aureus and Haemophilus influenzae, Common Pathogens in Cystic Fibrosis (CF), Collected from non-CF Paediatric Patients (SENTRY Surveillance 2015-2019)

(PDF, 301KB)

In Vitro Activity of Lefamulin against Bacterial Pathogens causing Pneumonia and Other Respiratory Tract Infections in Europe: Results from the SENTRY Surveillance Program (2019-2020)

(PDF, 1189KB)

Evaluation of Pleuromutilins Resistance Mechanisms Among Surveillance Clinical Isolates: Results from the Worldwide Surveillance Program for Lefamulin in 2019

ECCMID 2019

Nabriva presented 8 posters/e-posters at ECCMID 2019 that 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.

(PDF, 368KB)

Oral Lefamulin Demonstrates Favorable Safety and Tolerability in Adults With Community-Acquired Bacterial Pneumonia (CABP) in the Phase 3 Lefamulin Evaluation Against Pneumonia (LEAP 2) Study

Microbiology and Outcomes Among Patients Hospitalised With Suspected Community-Acquired Bacterial Pneumonia (CABP): A Multi-Centre Retrospective Cohort Study

(PDF, 437KB)

Bacterial Pathogen–Positive Patients Hospitalised With Suspected Community-Acquired Bacterial Pneumonia (CABP) Have Worse Outcomes Than Those With Negative or No Culture: A Multi-Centre Retrospective Cohort Study

(PDF, 473KB)

Antimicrobial Activity of Lefamulin Against a Large Longitudinal Collection of Clinical Bacterial Isolates Collected Worldwide Results From the SENTRY Antimicrobial Surveillance Programme

(PDF, 1928KB)

In Vitro Activity of Lefamulin Against Isolates Commonly Causing Community-Acquired Bacterial Pneumonia Collected During the SENTRY Surveillance Programme 2017 in Europe

(PDF, 4243KB)

Population Pharmacokinetic Analysis for Lefamulin Using Data From Healthy Volunteers and Infected Patients

(PDF, 518KB)

Pharmacokinetic-Pharmacodynamic Target Attainment Analyses to Support Lefamulin Dose Justification and Susceptibility Breakpoint Determinations for Patients With Community-Acquired Bacterial Pneumonia

ECCMID 2018

Nabriva presented 8 posters/e-posters at ECCMID 2018. Six posters were presented on lefamulin. Two from the phase 3 clinical development program, LEAP 1 IV to Oral switch study as monotherapy in adult patients with CABP, described the primary outcome measures of the first phase 3 trial as well as the safety and tolerability data. In 3 in vitro studies, presented were the bactericidal activity of lefamulin against S. pneumoniae, the activity of lefamulin and comparators against a contemporary collection of S. aureus isolates from Europe in 2016 as well as the evaluation of the activity of lefamulin and comparators against a collection of bacterial respiratory pathogens from Europe in 2016. One pre-clinical investigation of the distribution of lefamulin in tissue structures of the urogenital tract in rats was presented. Two epidemiologic investigations presented the hospital-level usage of high-risk antibiotics and associated CDI rates and epidemiology of bacteria in patients with culture-positive CABP who received empiric antibiotic therapy and were admitted to acute-care hospitals in the United States.

(PDF, 434KB)

Lefamulin Demonstrates Favorable Safety and Tolerability in Adults with Community-Acquired Bacterial Pneumonia (CABP) in the Phase 3 Lefamulin Evaluation Against Pneumonia (LEAP 1) Study

(PDF, 4963KB)

Tissue Distribution of [14C]-Lefamulin in the Urogenital Tract in Rats

(PDF, 935KB)

In Vitro Activity of Lefamulin Against Bacterial Pathogens Collected From Patients With Community- or Hospital-Acquired Respiratory Tract Infections: 2016 SENTRY Data From Europe

(PDF, 450KB)

In Vitro Bactericidal Activity of Lefamulin Against Streptococcus pneumoniae Isolates

(PDF, 523KB)

Correlation of high-risk antibiotic use and hospital-associated C. difficile infections: data from 195 US hospitals

(PDF, 391KB)

A multicentre evaluation of pathogen distribution in culture positive patients admitted with pneumonia in the US

(PDF, 434KB)

In Vitro Activity of Lefamulin against Contemporary Staphylococcus aureus Isolates from Patients in Europe (SENTRY 2016)

(PDF, 478KB)

Lefamulin is Non-inferior to Moxifloxacin in Adults with Community-Acquired Bacterial Pneumonia (CABP): The Phase 3 Lefamulin Evaluation Against Pneumonia (LEAP 1) Study

ECCMID 2017

Nabriva presented a total of 9 posters or oral presentations for lefamulin on Pharmacokinetics in fed and fasted healthy subjects, Population Pharmacokinetic analysis in plasma and epithelial lining fluid, Pharmacokinetic-Pharmacodynamic Target Attainment analyses to support the evaluation of intravenous and oral dosing regimens for the treatment of patients with Community-Acquired Bacterial Pneumonia (CABP), Activity against the key bacteria known to cause CABP (including multi-drug resistant strains) and STI - M. genitalium, and Mechanism of action: selectivity to inhibit bacterial protein synthesis at ECCMID in Vienna, Austria. (One podium presentation is not yet available.)

(PDF, 479KB)

Population Pharmacokinetic (PPK) Analysis for Lefamulin Plasma and Epithelial Lining Fluid (ELF) Exposures Using Data from Healthy Subjects

(PDF, 177KB)

Lefamulin Selectively Inhibits Bacterial Protein Synthesis

(PDF, 378KB)

In Vitro Activity of Lefamulin against Bacterial Pathogens Commonly Causing Community-Acquired Bacterial Pneumonia (CABP): 2015 SENTRY Data from Europe

(PDF, 242KB)

In Vitro Activity of Lefamulin against S. aureus from Hospital-Acquired Pneumonia (HAP) and Community-Acquired Pneumonia (CAP) Patients in Europe

(PDF, 256KB)

In Vitro Activity of Lefamulin against S. aureus Collected from Hospitalized Patients with Bacterial Pneumonia in Europe

(PDF, 254KB)

In Vitro Activity of Lefamulin against Global Collection of Respiratory Pathogens from Paediatric Patients from the 2015 Sentry Program

(PDF, 143KB)

Lefamulin is Highly Active In Vitro Against Multi-drug Resistant Mycoplasma genitalium Strains

(PDF, 746KB)

Pharmacokinetics and Safety of an Oral, Immediate-Release (IR) Tablet Formulation of Lefamulin in Fed and Fasted Healthy Subjects

ECCMID 2015

Nabriva presented posters on the Extended Spectrum Pleuromutilins (ESP) program at ECCMID.

(PDF, 180KB)

In Vitro and In Vivo Efficacy of Novel Extended Spectrum Pleuromutilins Against S. aureus and S. pneumoniae

(PDF, 508KB)

Kill Curves of the Novel Extended-Spectrum Pleuromutilin Antibiotic BC-9529

(PDF, 138KB)

Efficacy of Novel Extended Spectrum Pleuromutilins Against E. coli In Vitroand In Vivo

ECCMID 2014

Nabriva presented four posters on the Extended Spectrum Pleuromutilins (ESP) program at ECCMID.

(PDF, 60KB)

AntibacteriaL In Vitro Activity of Novel Extended Spectrum Pleuromutilins Against Gram-Positive and -Negative Bacterial Pathogens

Extended Spectrum Pleuromutilins: Mode-of-Action Studies

(PDF, 50KB)

In Vitro Metabolism and In Vivo Pharmacokinetics of Novel Extended Spectrum Pleuromutilin Antibiotics

(PDF, 50KB)

In Vivo Activity of Extended Spectrum Pleuromutilins in Murine Sepsis Model

ECCMID 2011

Nabriva presented data suggesting no major CYP450-mediated drug-drug interactions are expected with BC-3781.

(PDF, 200KB)

BC-3781: Evaluation of the CYP3A Interaction Potential

ECCMID 2010

Nabriva presented in vitro and in vivo efficacy data of pleuromutilin antibacterials BC-3205 and BC-3781 supporting further development in ABSSSI and CABP indications. Phase 1 data demonstrated safety and tolerability of the intravenous BC-3781 formulation.

Safety, Tolerance and Pharmacokinetics of Single and Repeat Doses of BC-3781, a Novel Antimicrobial

In Vivo Pharmacodynamic Activity of BC-3781

(PDF, 300KB)

Pharmacokinetic, Mass Balance and Tissue Distribution of [14C]-BC-3781 in Non-pigmented Rats