Nabriva Therapeutics Presents Extended Phase II Results
for Pleuromutilin Antibiotic BC-3781
Studies and Posters Presented at ICAAC in Chicago, Sept. 17-20th
Vienna, Austria- 15 September 2011- Nabriva Therapeutics, a biotechnology company focused on developing a new class of antibiotics for serious infections caused by resistant pathogens, today announced that a series of studies including data from the first Phase 2 study will be presented at the 51st Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Chicago, Illinois, USA. The studies further support that the Company’s lead product BC-3781, the first of a new class of systemically available pleuromutilin antibiotics, can be used both orally and intravenously for the treatment of bacterial skin and lung infections.
Nabriva’s CMO, Dr. William Prince will be presenting detailed data from the Phase II study in a talk entitled “A Phase 2 Study Comparing the Safety and Efficacy of Two Doses of BC-3781 Versus Vancomycin in Acute Bacterial Skin and Skin Structure Infections (ABSSSI)”. The study was the first to treat patients with a pleuromutilin administered intravenously and results showed that not only did BC-3781 have the same efficacy as Vancomycin, but that it was also safe and well-tolerated. The talk will take place during the session on “New Issues in Managing Skin and Skin Structure Infections (SSTI's)” at 1:30 pm on Sunday, September 18.
In addition, the posters to be presented will show important PK/PD data from the Phase II study, including an analysis of early time endpoints as suggested in the FDA’s draft guidance and a confirmation of the therapeutic dose of
BC-3781, plus data demonstrating the good tissue penetration of BC-3781 and the lack of resistance to BC-3781 world-wide.
Dr. Prince commented: “We are delighted with the quality of this Phase II study and look forward to presenting the excellent data. This is perhaps the most significant Phase II data for some time, given that we have proof-of-concept for the systemic use of a new class of antibiotics in man to treat ABSSSI, community-acquired bacterial pneumonia (CABP) and other indications.”
These studies will be presented at the 51st ICAAC in Chicago, held on September
17- 20, 2011. The titles and contributors to each poster mentioned above are as follows:
Population Pharmacokinetic (PPK) Analyses for BC-3781 Using Phase 2 Data
C. M. Rubino, B. Xue, S. M. Bhavnani, W. T. Prince, Z. Ivezic-Schoenfeld, W. W. Wicha, P. G. Ambrose
Pharmacokinetic-Pharmacodynamic (PK-PD) Analysis for Efficacy of
BC-3781 Using New Clinical Trial Endpoints in Patients with Acute Bacterial Skin and Skin Structure Infection (ABSSSI)
S. M. Bhavnani, J. P. Hammel, C. M. Rubino, C. C. Bulik, D. K. Reynolds, Z. Ivezic-Schoenfeld, W. W. Wicha, R. Novak, W. T. Prince, P. G. Ambrose
A Phase 2 Study Comparing the Safety and Efficacy of Two Doses of
BC-3781 Versus Vancomycin in Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
W. T. Prince, F. Obermayr, Z. Ivezic-Schoenfeld, C. Lell, W. W. Wicha, D. B. Strickmann, K. J. Tack, R. Novak
Antimicrobial Activity of BC-3781, an Investigational Pleuromutilin, Tested Against Organisms Isolated From Patients with Community-Acquired Respiratory Tract (CARTI) and Acute Bacterial Skin and Skin Structure (ABSSSI) Infections
H. S. Sader, D. J. Farrell, D. J. Biedenbach, R. N. Jones
The Pharmacokinetics of BC-3781 in Muscle and Adipose Tissue in Healthy Subjects
M. Zeitlinger, F. Obermayr, A. Burian, R. Badreslam, B. Burian, M. Müller, D. Strickmann, R. Novak, W. T. Prince
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About Nabriva Therapeutics
Nabriva Therapeutics is a biotechnology company focused on developing a new class of antibiotics for the treatment of serious infections caused by resistant pathogens. Nabriva’s lead systemic product, BC-3781, is being developed for the treatment of serious skin infections and bacterial pneumonia caused by S. aureus, S. pneumoniae, H. influenza, Mycoplasma, Legionella and other bacteria, including drug resistant strains such as MRSA and Vancomycin resistant E. faecium. In addition, Nabriva Therapeutics’ topical pleuromutilin product candidate, BC-7013, is in clinical Phase I. Nabriva Therapeutics has a proven track record in world-class medicinal chemistry, clinical expertise, a seasoned management team and solid IP. Nabriva’s current shareholders include: Phase4 Ventures HBM Partners, The Wellcome Trust, Global Life Science Ventures, Novartis Venture Fund and Sandoz. Nabriva Therapeutics is located in Vienna, Austria.