New Data Demonstrating In Vitro Potency of Dalbavancin Against Bacterial
Pathogens Presented at the 23rd Annual ECCMID Meeting
In Vitro Potency of Dalbavancin Has Remained Unchanged Since 2002
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 23^rd 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 (MIC[50/90], 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 MIC
results. CoNS was equally DAL-S (MIC, 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
(MIC, <=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
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 -- -- --* --
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 -- -- -- --
A copy of this poster is available on Durata's website:
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
About Durata Therapeutics
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,
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