NEW HAVEN, Conn., August 11, 2014 – Melinta Therapeutics today announced top-line results of a Phase 1 clinical study that demonstrated that the administration of single doses of 450 mg oral and 300 mg intravenous (I.V.) formulations of delafloxacin provide similar blood exposure. Delafloxacin is an investigational fluoroquinolone under development for acute bacterial skin and skin structure infections and uncomplicated gonorrhea.
In this study of 56 healthy adults, the oral formulation provided total comparable exposure (area under the curve-AUC) compared to I.V. administration, meeting pre-defined criteria. Peak blood levels were lower with the oral compared with I.V. dosing. Since antimicrobial activity for delafloxacin is correlated with AUC, these data support “step-down” from intravenous to oral dosing. Single doses in both groups were well tolerated.
Complete results from these studies will be 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 Washington, DC Convention Center.
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 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.