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news.Melinta Therapeutics has announced results of a Phase 1 study of delafloxacin, an investigational fluoroquinolone, in healthy adults that confirm a pharmacokinetic (PK) profile supportive of a single oral dose in the treatment of patients with uncomplicated gonorrhea.
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Specifically, results from this study of 20 healthy adults demonstrated that the mean time to peak plasma concentration following administration of a single 900mg dose of delafloxacin was approximately 1.4 hours, with a half-life of approximately 18 hours. Most common side effects were diarrhea, nausea and epistaxis (nosebleed).
Delafloxacin is an investigational fluoroquinolone antibiotic with in vitro activity against both Gram negative and Gram positive pathogens, including methicillin-resistant Staphylococcus aureus (MRSA).
Eugene Sun, M.D., Melinta’s executive vice president, research and development, added, "Mean total exposure and mean peak plasma concentration were also measured in this study.
These metrics combined with the rapid oral bioavailability and long half-life following a single oral dose of delafloxacin are supportive of our U.S. Phase 3 gonorrhea clinical program, in which we are comparing a single oral dose of delafloxacin to ceftriaxone."
Complete results from this study are being presented at the 54th annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), an American Society for Microbiology meeting. ICAAC is being held September 5-9, 2014 at the Walter E. Washington Convention Center in Washington, DC.