The FDA has fast-tracked Cempra's solithromycin to treat community acquired bacterial pneumonia.
The FDA has fast-tracked Cempra’s solithromycin to treat community acquired bacterial pneumonia (CABP).
Solithromycin (CEM-101) is currently under phase 3 clinical development for the treatment of CABP, and Cempra is planning to submit a New Drug Application for this indication in 2016.
The FDA previously designated solithromycin intravenous (IV) and oral capsules as a Qualified Infectious Disease Product (QIDP) for the treatment of community acquired bacterial pneumonia and solithromycin capsules as a QIDP for the treatment of gonorrhea.
Other clinical studies on solithromycin include a phase 3 trial in uncomplicated gonorrhea, phase 2 trials in chronic obstructive pulmonary disease (COPD) and nonalcoholic steatohepatitis (NASH), and a phase 1b trial in pediatric patients.
Phase 1 dose-escalation studies in healthy subjects have shown that solithromycin is well-tolerated and safe. The drug is the first fluoroketolide, a next-generation macrolide, which has potent activity against most macrolide-resistant strains.