Durata Therapeutics (NASDAQ: DRTX) today announced data from an in vitro study and surveillance results of its lead product candidate, dalbavancin, currently under investigation in two ongoing, global, Phase 3 clinical trials for the treatment of acute bacterial skin and skin structure infections (ABSSSI). The data, presented at the 52 nd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), demonstrate the potency of dalbavancin against numerous significant bacterial isolates in the United States and Europe.
Comparative In Vitro Activity of Dalbavancin (DAL) and Other Gram-Positive Agents Against a Recent Collection of European Bacterial Isolates (Simenauer, et al). Session Number 010, Presentation Number: C2-134
Study conclusions: On a MIC 90 (Minimum Inhibitory Concentration required to inhibit the growth of 90% of organisms) basis, dalbavancin was more potent than vancomycin, linezolid or daptomycin for every organism group studied. These findings indicate that dalbavancin continues to have potent activity against target pathogens isolated in Europe. (These in vitro data were generated by Dr. Dan Sahm and his team at Eurofins Medinet, Chantilly, Va.)
Update of Dalbavancin (DAL) Activity in the USA: Report from the SENTRY Program (2011). (Jones, et al). Session Number: 010, Presentation Number: C2-138Study conclusions: Year 2011 SENTRY Program surveillance results for dalbavancin (DAL) document sustained potent activity against Staphylococcus aureus (SA), coagulase-negative staphylococci (CoNS), beta-hemolytic streptococci (βHS), viridans gr. streptococci (VGS) and vancomycin-susceptible (VANC-S) enterococci, that averaged four-to 32-fold greater than vancomycin, daptomycin or linezolid. Further development of dalbavancin appears warranted by these in vitro potency criteria. (These in vitro data were generated from the laboratories of Dr. Ron Jones and his coauthors at the Jones Microbiology Institute Laboratories in North Liberty, Iowa.) “These results add to the growing body of evidence that dalbavancin is a highly potent agent against the Gram-positive bacteria associated with ABSSSI and many other infections of global concern,” said Durata Chief Medical Officer Michael Dunne, M.D. “We plan to use these data and clinical trial results to support our New Drug Application with the U.S. Food and Drug Administration for dalbavancin for the treatment of ABSSSI, which we continue to anticipate submitting in the first half of 2013.”