Melinta Therapeutics Presents Complete Delafloxacin Results from Phase 3 Study in Patients with Acute Bacterial Skin and Skin Structure Infections at ID Week
Melinta Therapeutics, a privately held company developing novel antibiotics to treat serious bacterial infections, today announced complete results from the first of two Phase 3 studies (RX-3341-302, NCT01811732) of delafloxacin, an investigational fluoroquinolone in late-stage development for the treatment of patients with acute bacterial skin and skin structure infections (ABSSSI).
Delafloxacin met the study’s primary endpoint, reduction in lesion size by at least 20% at 48-72 hours in the intent-to-treat (ITT) population without nonstudy antibiotics or major procedures, which was comparable to the response in the control arm receiving vancomycin plus aztreonam. Delafloxacin also was comparable to vancomycin+aztreonam in the study’s secondary endpoint of cure, defined as the complete resolution of signs and symptoms at the follow-up visit (Day 14).
Delafloxacin-treated patients experienced fewer treatment-emergent adverse events (AEs), and fewer discontinuations due to AEs than patients in the vancomycin+aztreonam arm. The most frequent AEs in the delafloxacin arm were infection, infusion site extravasation, diarrhea, and nausea. Melinta also provided an analysis of obese patients in this study. Among study participants, 214 patients had body mass index (BMI) of at least 30 kg/m2. More obese patients in the delafloxacin arm achieved cure than in the vancomycin+aztreonam arm.