Cempra Pharmaceuticals today announced the successful completion of Phase 1 clinical trials of its oral formulation of CEM-101, which showed good tolerability in those studies. The company also announced plans to submit an IND to the FDA to begin a Phase 1 study with the company's intravenous formulation of CEM-101 in mid-2010.
CEM-101 is a next-generation macrolide with potent activity against pneumococci, including macrolide- and quinolone-resistant strains. Bacterial pneumonia caused by multi-drug resistant pneumococci can result in clinical treatment failure and subsequent increases in healthcare costs.