Antibiotic-resistant bacterial pathogens have been a rising threat to human health for several years. Effectiveness of many antibacterial agents has declined worldwide limiting physicians' options to treat serious infections. Antibiotic drug resistance has a significant impact on morbidity and mortality and contributes heavily to healthcare system costs worldwide. The World Health Organization has stated that antibiotic resistance is one of the greatest healthcare challenges for the future.
Cempra is focused on developing differentiated antibiotics to confront the rising threat of antibiotic-resistant pathogens. Two products are in clinical development. Solithromycin is a novel, orally- and intravenously-active, broad-spectrum fluoroketolide. It is currently in a Phase III clinical trial in patients with moderate to moderately-severe coummunity-acquired bacterial pneumonia. A Phase I trial for the intravenous formulation is ongoing. Single-dose oral administration of solithromycin was tested in patients with uncomplicated gonorrhea in a Phase II clinical trial. TAKSTA™ (CEM-102, sodium fusidate) is an innovative dosing regimen of a product with a long history of safety and efficacy outside the U.S. against gram-positive organisms including MRSA. We have completed a Phase II trial in acute bacterial skin and skin structure infections and we initiated a Phase II clinical trial in patients with prosthetic joint infections.