Phase 2 Trial of Solithromycin (CEM-101) for Uncomplicated Urogenital Gonococcal Infections

Cempra announced the dosing of the first two patients enrolled in a Phase 2 clinical trial to evaluate the efficacy, safety and tolerability of solithromycin (CEM-101) in the treatment of uncomplicated urogenital gonococcal infections.

The Phase 2 clinical trial is an open-label, single-center study of 30 patients with clinically-proven uncomplicated gonorrhea that will be treated with a single 1,200mg oral dose of solithromycin. The primary outcome will be bacterial eradication at test of cure, which is seven days after treatment. 

Solithromycin is a fluoroketolide, the first of a new generation of macrolide-ketolide antibiotics. It exhibits potent in vitro activity against medically significant pathogens, including CA-MRSA, M. avium, malaria, enterococci and gonococci, as well as a broad range of respiratory pathogens, including Pneumococci, beta-hemolytic Streptococci, Staphylococci, Haemophilus, Legionella, Mycoplasma, Moraxella and Chlamydophila.

For more information call (919) 467-1716 or visit www.cempra.com.