NEW HAVEN, Conn., September 6, 2014 – Melinta Therapeutics today 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. 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.
About Melinta Therapeutics
Melinta Therapeutics, Inc. is dedicated to the discovery, development and commercialization of groundbreaking antibiotics to overcome drug-resistant, life-threatening infections. The need for new therapies for drug-resistant infections is widely recognized as one of the most serious public health issues facing the world today. To meet this need, Melinta Therapeutics is rapidly progressing its late-stage investigational antibiotic, delafloxacin, which is currently in Phase 3 development for acute bacterial skin and skin structure infections (ABSSSI) and uncomplicated gonorrhea. Delafloxacin has been designated a qualified infectious disease product (QIDP) for both ABSSSI, uncomplicated gonorrhea and community-acquired bacterial pneumonia by the U.S. Food and Drug Administration. A key initiative at Melinta is to develop, through the application of Nobel Prize-winning science, a new class of antibiotics designed to overcome the drug-resistant ESKAPE pathogens known to cause serious hospital infections. Melinta Therapeutics is privately held and backed by lead investor Vatera Healthcare Partners among other private investors. The company is headquartered in New Haven, CT with offices in Lincolnshire, IL.
For more information, visit www.melinta.com.