Cempra has two antibiotic candidates, solithromycin (CEM-101) and TAKSTA™ (CEM-102, sodium fusidate), in clinical trials. Both target the growing problem of antimicrobial resistance.
Solithromycin is a next-generation macrolide, the first fluoroketolide, which is active against macrolide-resistant bacteria and is more active than azithromycin or clarithromycin against most macrolide-susceptible bacteria. It is the first macrolide since azithromycin to have the potential to be administered both orally and intravenously (IV). Orally-administered solithromycin completed a Phase 3 clinical trial in patients with community acquired bacterial pneumonia, and the IV formulation is being evaluated in a Phase 3 clinical trial for the same indication. Cempra is also conducting a Phase 3 trial of oral solithromycin in patients with uncomplicated gonococcal infections.
TAKSTA (sodium fusidate) is an agent with a long history of safety and efficacy outside the U.S. It is active against gram-positive pathogens, including both hospital- and community-acquired methicillin-resistant S. aureus (MRSA). Cempra has developed a loading dose regimen that is designed to maximize efficacy and bacterial coverage while minimizing resistance development. This loading dose regimen was demonstrated to be well tolerated and effective against S. aureus, including MRSA, in a Phase 2 clinical trial in patients with acute bacterial skin and skin structure infections (ABSSSI). Sodium fusidate has been used successfully as a long-term treatment (months to years) for bone and joint infections in Europe and Australia. Because TAKSTA has been shown to be well tolerated and active against contemporary staphylococcal strains, Cempra initiated a Phase 2 clinical trial in patients with prosthetic joint infections in December 2012. |
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