Melinta Therapeutics Initiates Phase 3 Study of Baxdela in Hospital-Treated Community-Acquired Bacterial Pneumonia
Melinta Therapeutics, a privately held company developing novel antibiotics to treat bacterial infections, announced the initiation of an international Phase 3 trial (study ML-3341-306) comparing Baxdela (delafloxacin), an investigational fluoroquinolone, to moxifloxacin for the treatment of hospitalized patients with radiographic evidence of community-acquired bacterial pneumonia (CABP). The primary efficacy endpoint is improvement at 96 hours after the first dose in at least two of the following symptoms: chest pain, frequency or severity of cough, amount of productive sputum, and difficulty breathing. Additional efficacy and safety measures will also be captured. The U.S. FDA has designated Baxdela as a Qualified Infectious Disease Product (QIDP) for community-acquired bacterial pneumonia.