Overview

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 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-active, broad-spectrum fluoroketolide that has completed multi dose Phase I clinical studies for the oral formulation in healthy subjects recently, and completed a Phase II trial for the oral formulation. A Phase I trial for intravenous formulation is ongoing. TAKSTATM (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 are planning a Phase II trial in prosthetic joint infections and Phase III trials in acute bacterial skin and skin structure infections.