Tetraphase Pharmaceuticals, Inc., yesterday presented new clinical and preclinical data for its lead drug candidate, TP-434, which demonstrated the novel antibiotic as a once-daily intravenous (I.V.) monotherapy capable of treating multidrug-resistant gram-negative pathogens while also having potency and broad spectrum coverage of other serious and multidrug-resistant gram-positive pathogens. Additionally, Tetraphase presented new data that showed the potential for TP-434 to be effective in an oral formulation, which makes TP-434 ideally suited as a first-line IV antibiotic with oral step-down for severe and life-threatening bacterial infections. These data were presented in an oral session and in two poster sessions at the 2010 Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Boston, MA, being held September 12-15. Tetraphase is a clinical stage biopharmaceutical company utilizing breakthrough synthetic chemistry technology to discover and develop next-generation antibiotics.
“TP-434's unprecedented bacterial spectrum, combined with successful early clinical data positions TP-434 as a potential first-line therapy for severe and life-threatening bacterial infections.”
In the Poster Summary Session on "Novel Antimicrobial Agents and Strategies" on Sunday, September 12, Tetraphase reviewed key data relating to TP-434, highlighting Phase I clinical data that shows TP-434 was safe and well-tolerated with once-daily I.V. dosing, and preclinical data demonstrating TP-434's potency and efficacy against a broad range of multidrug-resistant and gram-negative pathogens. The main conclusions included:
- TP-434 was shown in preclinical studies to be efficacious against both highly resistant gram-negative pathogens, for which there are few other effective antibiotics, and the broadest reported range of coverage of other bacterial pathogens, including the multidrug-resistant gram-positive, anaerobic, and atypical species.
- Data on TP-434's pharmacokinetic profile (in human studies) demonstrated the compound's potential for use as a once-daily therapy, providing exposures significantly higher than marketed in-class competitors.
- Data from a Phase 1 study demonstrated the potential for TP-434 to be orally bioavailable.
"While there are other novel approaches in development that also address gram-negative pathogens, the data on TP-434 stand out because they reveal TP-434 to have a very broad spectrum, including difficult-to-treat pathogens and drug-resistant superbugs," said Guy Macdonald, President and Chief Executive Officer of Tetraphase. "TP-434's unprecedented bacterial spectrum, combined with successful early clinical data positions TP-434 as a potential first-line therapy for severe and life-threatening bacterial infections."
"Our plans include additional development of the oral formulation of TP-434 as a follow-on product opportunity to our TP-434 I.V. program, which would offer a unique advantage in the antibiotics market where there are few oral antibiotics capable of addressing multidrug-resistant bacterial infections," added Mr. Macdonald.
In the Sunday poster presentations "Phase I Single and Multiple Ascending Dose Study of a Broad-Spectrum Fluorocycline, TP-434" and "Population Pharmacokinetic Modeling of TP-434, a Novel Fluorocycline, Following Single and Multiple Dose Administration," the data showed the potential utility of TP-434 given as once-daily IV doses in the treatment of severe bacterial infections caused by multidrug-resistant gram-negative pathogens. By population pharmacokinetic analyses, TP-434 is expected to have utility at dose regimens up to and including 2 mg/kg/day.
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