Vienna, Austria, 08 September 2014: Nabriva Therapeutics AG, a biotechnology company focused on developing pleuromutilins, a new class of antibiotics for treatment of serious infections caused by resistant pathogens, today announced the presentation of a poster on BC 3781, a novel pleuromutilin antibiotic which is being developed for oral and intravenous administration for the treatment of severe infections, at the 54th Interscience Conference on Antimicrobial Agents and Chemotherapy in Washington DC on Sunday 7th September, from 11am to 1pm EDT.
Dr Colin Broom, Chief Executive Officer of Nabriva, commented: “These data are highly encouraging for BC-3781 and provide strong support for our late stage development plans for community acquired bacterial pneumonia and other respiratory infections. We are delighted that the organizers accepted these data for presentation at such a prestigious conference.”
The following poster was presented in the Clinical Pharmacology of Anti-Infective Agents in Clinical Development session:
Pharmacokinetics of BC-3781 in the Pulmonary Epithelial Lining Fluid of Healthy Subjects M. Zeitlinger, D. B. Strickmann, W. W. Wicha, R. Schwameis, B. Burian, M. Müller, W. T. Prince; 1Med. Univ. of Vienna, Vienna, Austria, 2Nabriva Therapeutics AG, Vienna, Austria
The study examines the pharmacokinetics (PK) of BC-3781 in the epithelial lining fluid in comparison to the plasma. Since knowledge of the PK at the site of infection is crucial in the development of antibiotics, for the treatment of respiratory tract infections such as community- and hospital-acquired bacterial pneumonia (CABP & HABP) drug penetration into the pulmonary epithelial lining fluid (ELF) is a pre-requisite. The study, whereby BC-3781 was administered to 12 healthy male subjects, was safe and well tolerated and there were no clinically relevant changes in laboratory values. Main conclusions found were that after a single intravenous dose of BC-3781, exposure levels in ELF were comparable to total plasma levels and considerably exceeded free plasma levels. The individual BC-3781 concentration levels in ELF equilibrated with the plasma rapidly after the end of infusion.
For further information, please contact:
Nabriva Therapeutics AG
Dr Colin Broom
Chief Executive Officer
Tel: +43 (0)1 740 930
Email: office@nabriva.com
Hume Brophy
Mary Clark, Supriya Mathur, Hollie Vile
Tel: +44 2034405654
Email: nabriva@humebrophy.com
Notes to editors
About Nabriva Therapeutics AG
Nabriva Therapeutics is a biotechnology company focused on developing a new class of antibiotics, the pleuromutilins, for the treatment of patients with serious infections caused by multi-drug resistant pathogens. Nabriva’s world-class medicinal chemistry expertise has achieved an industry first with the development of both intravenously administered and orally available pleuromutilins that are therefore ideal for i.v. to oral switch therapy.
Lefamulin (BC-3781)
Nabriva’s lead product lefamulin (BC 3781) is about to enter Phase 3 studies. Due to its broad spectrum, oral and i.v. formulations and a favourable safety profile, lefamulin is the first of a new class of antibiotics ideally positioned for the treatment of community-acquired bacterial pneumonia (CABP), plus hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP), as well as acute bacterial skin and skin structure infections (ABSSSI), with potential in several other indications (sexually transmitted infections including MDR gonorrhoea; osteomyelitis) including paediatric use.
Extended Spectrum Pleuromutilins
Pleuromutilins broadening Gram-negative coverage (extended spectrum pleuromutilins, ESP) are the latest addition to the Nabriva portfolio. Nabriva’s preclinical program expands the activity of pleuromutilins to include major enteric Gram-negative pathogens such as E. coli and K. pneumoniae. The targeted indications for the ESP extend beyond the current use of the first-generation pleuromutilins, thereby filling important gaps in treatment options of both marketed antibiotics and compounds in development.
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