Cempra Pharmaceuticals completes Phase 1 clinical trials of CEM-101 macrolide

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.

A Phase 2 trial with the oral formulation of CEM-101 is expected to begin in the second quarter of 2010 in patients with moderate to moderately severe community-acquired bacterial pneumonia (CABP).  Full details of the Phase 1 studies will be presented at the upcoming European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) on April 10 to 13 in Vienna, Austria.

"Results from the Phase 1 studies suggest that CEM-101 is safe and well-tolerated and has a pharmacokinetic profile that will allow for once-daily oral dosing," said J. Carl Craft, M.D., head of medical affairs, Cempra Pharmaceuticals, and a member of Cempra's Scientific Advisory Board. "CEM-101 has enormous potential because of its broad spectrum activity, including activity against resistant strains, its capacity to be administered both orally and intravenously and its unique pattern of ribosomal binding, which may limit the development of drug-resistant strains.  We expect to initiate Phase 2 studies in patients with moderate to moderately severe community-acquired bacterial pneumonia in the coming months."

Prabhavathi Fernandes, Ph.D., president and CEO of Cempra noted, "Bacterial pneumonia is a serious infection, particularly in the elderly population.  Macrolides have been a mainstay of treatment for this and other indications but drug resistance has increased to more than 25% of clinical isolates.  Doctors are looking for new and convenient alternatives and CEM-101 could be an important option.  We look forward to advancing CEM-101 further into clinical development."

CEM-101 is expected to be the first macrolide to have an intravenous formulation available in the U.S. since intravenous azithromycin was approved in 1997, a significant development that carves a path for studies in moderate to severe community-acquired bacterial pneumonia (CABP).

SOURCE Cempra Pharmaceuticals