Melinta Therapeutics’ Baxdela™ Successfully Achieves Endpoints in Confirmatory Phase 3 Study in Patients with Hospital-Treated Skin Infections
Study first to prospectively evaluate novel IV-to-oral antibiotic vs. vancomycin standard of care in population enriched for obesity and associated co-morbidities
New Haven, CT, May 12, 2016 — Melinta Therapeutics, a privately held company developing novel antibiotics to treat serious bacterial infections, today announced top-line results from the second Phase 3 study (RX-3341-303 NCT01984684) of Baxdela (delafloxacin), an investigational anionic quinolone in development for the treatment of patients with acute bacterial skin and skin structure infections (ABSSSI). Baxdela met the primary endpoints required by the U.S. Food and Drug Administration (FDA) as well as the European Medicines Agency (EMA) in this confirmatory pivotal study. Baxdela, with its broad spectrum activity against Gram-positive and Gram-negative bacteria, including MRSA, was tested as an intravenous (IV)-to-oral monotherapy against standard of care, IV-only combination of vancomycin plus aztreonam.