NEW HAVEN, Conn., May 5, 2014 – Melinta Therapeutics today announced that patient enrollment has commenced in a Phase 3 trial of oral and intravenous (I.V.) delafloxacin, a novel fluoroquinolone, in adults with acute bacterial skin and skin structure infections (ABSSSI). This study compares the efficacy and safety of both formulations of delafloxacin to a control regimen of I.V. vancomycin plus aztreonam. Delafloxacin was designated a Qualified Infectious Disease Product (QIDP) by the FDA for the treatment of ABSSSI, a classification that provides an additional five years of market exclusivity (for a total of ten years) following approval.
Dr. Eugene Sun, executive vice president, research and development of Melinta, commented, “ABSSSI is a broad term describing a variety of challenging skin infections, often involving methicillin-resistant Staphylococcus aureus (MRSA), which are best addressed with multiple treatment options. To address this need, Melinta is developing oral and I.V. formulations of delafloxacin to provide flexibility in the management of these patients.”
Results from this Phase 3 study (ML-3341-303; NCT01984684) and those from a second, ongoing Phase 3 study of I.V. delafloxacin (ML-3341-302; NCT01811732) are expected to support the filing of regulatory applications with the U.S. Food and Drug Administration (FDA) and foreign regulators.
Mary Szela, Melinta’s chief executive officer concluded, “We believe that the development of an oral formulation of delafloxacin in addition to an I.V. formulation will be an important factor for hospitals and physicians when evaluating treatment options for their patients.”
About the Study
The ML-3341-303 study is a double-blind and double-dummy design in which approximately 660 patients with ABSSSI are expected to be enrolled. Patients will be randomized to receive either delafloxacin or vancomycin plus aztreonam. Patients in the delafloxacin arm will receive I.V. delafloxacin twice daily for three days, after which they will switch to oral delafloxacin twice daily. Patients in the control arm will receive I.V. vancomycin plus aztreonam every 12 hours. All patients will receive a minimum of 5 days of dosing, with a maximum of 14 days of treatment at the investigators’ discretion.
About Melinta Therapeutics
Melinta Therapeutics 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. 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 venture firms. The company is headquartered in New Haven, CT with offices in Lincolnshire, IL.
For more information, visit www.melinta.com.