Ligand Pharmaceuticals Incorporated announced that its partner Melinta Therapeutics reported positive top-line results from the first of two Phase 3 PROCEED studies (study RX-3341-302, NCT01811732) to evaluate delafloxacin, an investigational fluoroquinolone, compared with vancomycin + aztreonam for the treatment of patients with acute bacterial skin and skin structure infections (ABSSSI). Delafloxacin met the study' s primary objective endpoint of a reduction in the measurement of lesion erythema at the primary infection site at 48- to- 72 hours, the endpoint required by the U.S. Food and Drug Administration (FDA). Delafloxacin also was comparable to vancomycin in the studyâ s secondary endpoints, including investigator assessment of signs and symptoms of infection at the follow-up visit, a metric required by the European Medicines Agency (EMA).

Melinta reports that delafloxacin was shown to be well tolerated among study participants. Mild gastrointestinal symptoms were the most common treatment-related adverse events reported for delafloxacin, and rarely led to study discontinuation. Melinta expects to make complete results from this study available as a presentation at an upcoming medical meeting and a publication in a peer-reviewed medical journal.