Cempra Inc.,a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, has dosed first two patients enrolled in a phase II clinical trial to evaluate the efficacy, safety and tolerability of solithromycin in the treatment of uncomplicated urogenital gonococcal infections.
The phase II clinical trial is an open-label, single-centre study of 30 patients with clinically-proven uncomplicated gonorrhea that will be treated with a single 1,200 mg oral dose of solithromycin. The primary outcome will be bacterial eradication at test of cure, which is seven days after treatment. Safety and tolerability outcome measures will be investigated.
“Antibiotic-resistant Neisseria gonorrhoeae infections are becoming an increasing public health problem,” said Prabhavathi Fernandes, chief executive officer of Cempra. “A recent peer-reviewed publication demonstrated that solithromycin has in vitro activity against N. gonorrhoeae including most antibiotic-resistant strains. This clinical study is designed to determine the potential of solithromycin as a future treatment option for patients with these infections. We look forward to presenting top-line results by the end of this year.”
Solithromycin is the first fluoroketolide with a number of attributes that may provide clinically important advantages over several comparator products: Eight to 16 times more potent than azithromycin and is active against organisms that have become resistant to azithromycin; Potent in vitro activity against a broad range of respiratory pathogens, including pneumococci, beta-hemolytic streptococci, staphylococci, Haemophilus, Legionella, Mycoplasma, Moraxella and Chlamydophila; Potent in vitro activity against other medically significant pathogens, including CA-MRSA, M. avium, malaria, enterococci and gonococci; Good tolerability to date as demonstrated in phase I and II trials of the oral formulation; Low resistance frequency in vitro; No pyridine side chain, unlike telithromycin; the pyridine moiety is believed responsible for certain adverse effects observed with telithromycin (Ketek); Excellent tissue distribution and intracellular tissue concentrations, including lung epithelial lining fluid and alveolar macrophages; Oral and IV formulations concurrently in development; Once-daily dosing.