Company Notice – Melinta Therapeutics has stopped the gonorrhea Phase 3 PROCEEDING (Prove Clinical Efficacy and Effectiveness of Delafloxacin in Neisseria Gonorrhoeae) study (study RX-3341-304, NCT02015637) based on an independent interim review that concluded that the single delafloxacin monotherapy dose may not be sufficient to treat some patients. There have been no serious adverse events related to delafloxacin in the study, and no significant safety issues identified through ongoing medical monitoring of the study. Development will continue for delafloxacin as a treatment for acute bacterial skin and skin structure infections (ABSSSI).
About the PROCEEDing Study
The PROCEEDING study was a comparative evaluation of the single-dose efficacy of oral delafloxacin versus the single-dose efficacy of an intramuscular injection of ceftriaxone in individuals with uncomplicated urogenital gonorrhea.
Delafloxacin, is an investigational fluoroquinolone antibiotic currently in Phase 3 clinical development for ABSSSI. The PROCEED studies (studies 302 and 303) are Phase 3, multicenter, randomized, double-blind, active-controlled trials to evaluate the efficacy and safety of delafloxacin compared with vancomycin + aztreonam in patients with acute bacterial skin and skin structure infections.
About Melinta Therapeutics
Melinta Therapeutics, Inc. 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). Delafloxacin has been designated a qualified infectious disease product (QIDP) for both ABSSSI and community-acquired bacterial pneumonia by the U.S. Food and Drug Administration. 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 private investors. The company is headquartered in New Haven, CT with offices in Lincolnshire, IL.