- Cempra's antibiotic-in-development for treatment of community-acquired pneumonia (CAP), solithromycin, could become the first macrolide approved since 1988—and it could become a major part of the arsenal of drugs to combat antibiotic-resistant bacterial infections.
- Cempra is planning a $100 million stock sale to raise money.
- With respect to solithromycin, the company's planned next steps are completion of phase IV studies, filing the new drug application (NDA), and working on pre-commercial activities in anticipation of a launch.
Solithromycin is part of a class of antibiotics known as macrolides, which include antibiotics that are used to treat CAP. Although azithromycin is a frequently used macrolide for treatment of CAP, Cempra chose not to use azithromycin as part of clinical trials due to CAP's growing resistance to that drug.
Instead, solithromycin was tested in phase III trials against Bayer's Avelox (moxifloxacin), a flouroquinolone. Solithromycin was deemed non-inferior to Avelox in a trial that evaluated solithromycin in pill form. A second phase III trial focusing on the effectiveness of the IV version of solithromycin is currently enrolling patients.