Corporate Overview

novel antibiotics, antibacterial products,Solithromycin, TAKSTA, sodium fusidate Founded in 2006, Cempra Inc. is a clinical-stage pharmaceutical company focused on developing antibacterials to meet critical medical needs. Two lead antibacterial products, both in the treatment of infectious diseases, address the urgent and increasing need for new treatments targeting drug-resistant bacterial infections in both the hospital and the community. Cempra is committed to developing commercially and medically differentiated products that provide a treatment alternative to address patient needs. The company is also utilizing its series of proprietary lead compounds from our novel macrolide library for uses such as the treatment of chronic inflammatory diseases, endocrine diseases and gastric motility disorders.

Addressing the need for differentiated antibiotics that act against drug-resistant bacteria

Antibiotic resistance has 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 solutions to this problem and addressing the future needs of patients.

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 Phase II clinical trials in patients with community-acquired bacterial pneumonia and the IV formulation has been evaluated in a Phase I clinical trial in healthy volunteers.  A Phase III clinical trial in which oral solithromycin is being tested in patients with community-acquired bacterial pneumonia has been initiated in December 2012.  Cempra also conducted a small Phase II 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 II 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 II clinical trial in patients with prosthetic joint infections in December 2012.

Led by an accomplished management team dedicated to shape the future of the company and the industry

Cempra is led by a management team with extensive drug development and commercialization experience in the area of anti-infectives. The company is supported by a world-class Scientific Advisory Board comprised of renowned industry and infectious disease experts.