Nabriva Therapeutics Presented Data on Potency, Safety, Tolerability and Pharmacokinetics of Pleuromutilin Antibiotic BC-3781
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Nabriva Therapeutics Presented Data on Potency, Safety, Tolerability and
Pharmacokinetics of Pleuromutilin Antibiotic BC-3781
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Five Posters Presented at ICAAC, Denver, CO, Sept. 10-13, 2013
Vienna, Austria, September 13, 2013 - Nabriva Therapeutics AG, a biotechnology
company focused on developing pleuromutilins, a new class of antibiotics for
serious infections caused by resistant pathogens, today announced the
presentation of five posters on BC-3781, a novel pleuromutilin antibiotic in the
development for oral and intravenous administration for the treatment of severe
infections, at the 53rd Interscience Conference on Antimicrobial Agents and
Chemotherapy (ICAAC) in Denver, Colorado, USA. The studies further support the
development of BC-3781 to treat complicated bacterial skin and respiratory
infections and sexually transmitted diseases (STD). Results of this work were
presented on September 10th and 12th at ICAAC.
Dr. William Prince, Nabriva's Chief Medical Officer said: "To date more than
400 people have been treated with BC-3781 administered intravenously or orally.
Sixteen clinical Phase 1 studies and one Phase 2 study in patients with
complicated skin and skin structure infections demonstrated the safety and
efficacy of BC-3781. The pleuromutilin antibiotic is well tolerated and shows a
good safety profile irrespective of the administration route. The presented
Phase 1 study 'Safety, Tolerability and Pharmacokinetics of Orally Administered
BC-3781, a Novel Antimicrobial' demonstrated the suitability of the
pleuromutilin for oral administration, allowing for a potential switch from
intravenous to oral delivery in a planned Phase 3 clinical study".
The following posters were presented:
Safety, Tolerability and Pharmacokinetics of Orally Administered BC-3781, a
Novel Antimicrobial
W.W. Wicha, C. Lell, D.B. Strickmann, W. Heilmayer, Z. Ivezic-Schoenfeld, W.T.
Prince
Poster # A-012
After administration as a 600 mg IR-tablet BC3781 was rapidly absorbed and well
tolerated. The exposure after a single oral dose in terms of AUC was similar to
that observed after single doses of 150 mg i.v. BC-3781 in phase 1 studies and
in patients with ABSSSI. Food caused a small reduction in AUC(0-inf). Based on
the data obtained, switch therapy using 150 mg i.v. followed by 600 mg oral is
possible.
Comparative Pharmacodynamics of BC-3781 in Murine Streptococcus pneumoniae Thigh
and Lung Infection Models
W.W. Wicha, E. Fischer, B. Kappes, Z. Ivezic-Schoenfeld
Poster # A-013
BC-3781 showed good activity against S. pneumoniae infections with an enhanced
activity in lung tissues, compared to thigh. The PKPD information obtained in
this study would support a study against respiratory tract infections and
provides a robust basis for target attainment analysis.
In Vitro Synergy/Antagonism Of The Pleuromutilin BC-3781 With Selected
Antibiotics Against Grampositive And Gramnegative Bacteria
S. Paukner, A. Stoneburner, Z. Ivezic-Schoenfeld, C. Pillar
Poster # E-1161
Overall, BC-3781 was confirmed to have largely 'no interaction', neither
antagonism nor synergy, when combined with other antibiotics against Gram-
positive or Gram-negative organisms, including those with important resistance
phenotypes (e.g. MRSA and ESBL) suggesting that there is no potential issue for
combination therapy when Gram-negative coverage is necessary.
Accumulation of the Pleuromutilin Antibiotic BC-3781 in Murine Macrophages and
Effect of Lung Surfactant on the BC3781 In Vitro Activity
S. Paukner, K. Krause, A. Gruss, T. Keepers, M. Gomez, A. Bischinger, D.B.
Strickmann, Z. Ivezic-Schoenfeld
Poster # A-011
Overall, BC-3781 accumulated in murine macrophages at clinically relevant
extraceulluar concentrations and the antimicrobial potency of BC-3781 was
unaffected by lung surfactant. Together with the high tissue penetration into
the lung, these data support the investigation of BC-3781 in bacterial
pneumonia.
In Vitro Activity Of The Novel Pleuromutilin BC-3781 Tested Against Bacterial
Pathogens Causing Sexually Transmitted Diseases (STD)
S. Paukner, A. Gruss, T. R. Fritsche, Z. Ivezic-Schoenfeld, R. N. Jones
Poster # E-1183
Overall, BC-3781 displayed potent activity against the most relevant bacterial
pathogens causing STD warranting further investigations on the potential of BC-
3781 in this indication.
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 and sexually transmitted diseases. Nabriva's lead product BC-3781 is a
broad spectrum agent being developed for the treatment of serious skin
infections and community-acquired bacterial pneumonia (CABP) caused by
S. aureus, S. pneumoniae, H. influenzae, M. pneumoniae, L. pneumophila and
other bacteria, including drug resistant strains such as methicillin-resistant
S. aureus (MRSA) and vancomycin-resistant E. faecium. Proof of concept for the
systemic use of BC-3781 in humans was achieved in a Phase 2 trial in patients
with acute bacterial skin and skin structure infections (ABSSSI). BC-3781 is a
Phase 3 ready product for ABSSSI and CABP indications. In addition, BC-7013, a
topical treatment for dermatological diseases has completed Phase 1 trials. In
preclinical studies, the company is developing extended spectrum pleuromutilins
(ESPs) with broad activity against both Gram-positive and Gram-negative
bacterial infections. In particular, the ESPs are focused on the high unmet
medical need to treat Urinary Tract Infections and complicated Intra Abdominal
Infections, plus other serious bacterial infections.
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, Wellcome
Trust, Global Life Science Ventures, Novartis Venture Fund and Sandoz. Nabriva
Therapeutics is located in Vienna, Austria.
For more information on Nabriva please visit www.nabriva.com.
Contact us
NABRIVA THERAPEUTICS AG MC SERVICES
Ralf Schmid Raimund Gabriel
Chief Executive Officer Managing Partner
T +43 (0)1 740 930 T +49 89 210 228-30
OFFICE(at)NABRIVA.COM Raimund.gabriel(at)mc-services.eu
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Datum: 13.09.2013 - 13:02 Uhr
Sprache: Deutsch
News-ID 296489
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