CHICAGO, April 29, 2013 (GLOBE NEWSWIRE) -- Durata Therapeutics, Inc. (Nasdaq:DRTX) today announced data from surveillance results of its lead product candidate, dalbavancin, under investigation for the treatment of acute bacterial skin and skin structure infections (ABSSSSI). The data, presented at the 23rd Annual European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), demonstrate that in vitro potency of dalbavancin remains consistent with earlier surveillance reports.
Dalbavancin Activity in the USA: Reported from the SENTRY Programme (2012)
Authors: R.N. Jones, R.K. Flamm, H.S. Sader, B.P. Goldstein, M. Dunne (North Liberty, Morristown, US) Poster #: P1646
Study conclusions: Year 2012 SENTRY Program surveillance results for dalbavancin (DAL) document sustained potent activity against SA, CoNS, βHS, VGS and VAN-S enterococci, that averaged four to 32-fold greater than VAN, DAP or LZD. Further development of DAL appears warranted from these in vitro potency results for an antibiotic requiring very infrequent dosing.
Further Study Details
Dalbavancin potency was assessed in the 2012 SENTRY Antimicrobial Surveillance Program among 1,589 isolates sampled from the nine USA Census regions (27 medical centers) to update the 38,813 organism collections reported for 2006-2011 (2011 and 2012 ICAAC). Researchers monitored Gram-positive cocci included Staphylococcus aureus (SA; 1,000/50% MRSA), coagulase-negative staphylococci (CoNS; 122); Enterococcus faecalis (30); E. faecium (30); Streptococcus pyogenes (151); S. agalactiae (134; 336 β-haemolytic streptococci overall) and viridans group streptococci (VGS; 71). All susceptibility (S) testing used CLSI reference broth microdilution methods and EUCAST interpretations for comparison agents.
Surveillance data showed that dalbavancin (MIC50/90, 0.06/0.06 mg/L) was eight to 16-fold more active than daptomycin (DAP), linezolid (LZD) and vancomycin (VAN), against SA; with MSSA and MRSA having the same MIC90 results. CoNS was equally DAL-S (MIC90, 0.06 mg/L). The highest staphylococcal DAL MIC was only 0.25 mg/L as it was in 2011. β-haemolytic streptococci (βHS) and VGS had DAL MIC values ranging from <=0.03 to 0.25 mg/L (MIC90, <=0.03-0.06 mg/L) and only enterococci showed elevated DAL MIC results. VanA phenotype-resistant E. faecalis or E. faecium had non-S DAL MIC values (>=4 mg/L). VanB resistance strains were DAL-S (MIC, <=0.12 mg/L).
All cited DAL quantitative values were totally consistent with earlier surveillance data (2006-2011), without evidence of MIC creep. LZD-R CoNS was detected (modified target mechanism).
| Cum. | % | inhibited | at | DAL | MIC | (µg/ml): | |
| Organism (no.) | ≤ 0.03 | 0.06 | 0.12 | 0.25 | 0.5 | 1 | ≥ 2 |
| S. aureus | |||||||
| MSSA (500) | 21.6 | 91.6 | 100.0 | -- | -- | --* | -- |
| MRSA (500) | 16.8 | 90.0 | 99.8 | 100.0 | -- | --* | -- |
| CoNS (122) | 49.2 | 91.8 | 99.2 | 100.0 | -- | -- | --* |
| βHS (336) | 91.7 | 97.9 | 99.1 | 100.0 | --* | -- | -- |
| VGS (71) | 84.5 | 98.6 | 100.0 | -- | -- | --* | -- |
| Enterococci | |||||||
| Van-susceptible (33) | 0.0 | 66.7 | 93.9 | 100.0 | -- | --* | -- |
| VanA (25) | 0.0 | 0.0 | 0.0 | 4.2 | 4.2 | 12.5 | 100.0 |
| VanB(2) | 50.0 | 0.0 | 100.0 | -- | -- | -- | -- |
| *=vancomycin MIC90 | |||||||
A copy of this poster is available on Durata's website: www.duratatherapeutics.com.
Dalbavancin is an intravenous antibiotic product candidate under investigation for once-weekly dosing, which we believe may facilitate the treatment of patients with ABSSSI in both the in-patient and out-patient settings, potentially reducing the length of a patient's hospital stay or avoiding hospital admission altogether, with an impact on the overall cost of care for these patients.
Durata Therapeutics is a pharmaceutical company focused on the development and commercialization of novel therapeutics for patients with infectious diseases and acute illnesses. Durata has completed two global Phase 3 clinical trials with its lead product candidate, dalbavancin, under investigation for the treatment of patients with acute bacterial skin and skin structure infections, or ABSSSI.
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