You have probably heard all those stories about antibiotic resistant bacteria. Chapel Hill drug developer Cempra Inc. has move another step closer to European approval of one solution. Cempra, a clinical-stage pharmaceutical company developing new antibiotics effective against resistant strains of bacteria, has received European validation of its treatments for community-acquired bacterial pneumonia (CABP), a move that begins the European review process.
The validation by European regulators includes both oral capsule and intravenous formulations of solithromycin, which is effective against a range of antibiotic resistant bacteria, a growing threat worldwide. The drug, marketed as Solithera, is also under review by the U.S. Food and Drug Administration.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) will now begin their assessment of solithromycin through the centralized review procedure. If the CHMP review results in a positive opinion, the next step would be for the European Commission to grant marketing clearance for solithromycin, which would apply to all EU member states.
“With increasing failure rates of primary antibiotic therapy and increasing hospitalization rates due to CABP in the EU, there is an urgent need for new safe and effective oral and intravenous antibiotic therapies,” said Prabhavathi Fernandes, Ph.D., president and chief executive officer of Cempra.
Solithromycin is a highly potent next-generation antibiotic macrolide, the first fluoroketolide, which has potent activity against most macrolide-resistant strains. Studies have shown potent activity against S. pneumoniae as well as an extended spectrum of activity against community-acquired methicillin resistant S. aureus (CA-MRSA), streptococci, haemophilus, enterococci, Mycobacterium avium and in animal models of malaria and atypical bacterial.
Solithera (solithromycin, CEM-101) has successfully completed two Phase 3 clinical trials for community acquired bacterial pneumonia (CABP) and applications for approval for both intravenous and oral capsule formulations have been accepted for review by the FDA and the EMA.
Cempra has also synthesized novel macrolides for non-antibiotic uses such as the treatment of chronic inflammatory diseases, endocrine diseases and gastric motility disorders. Cempra was founded in 2006.
In the United States, CABP, and in the European Union, CAP, are the number one causes of death from an infection, particularly in the very young and in the elderly. CABP is one of the most commonly diagnosed bacterial infections in the U.S. resulting in 5 to 10 million cases per year. Although many strains of the primary CABP pathogen, Streptococcus pneumoniae, are resistant to currently-approved macrolides, this class of antibiotic remains among the most commonly prescribed antibacterial drugs for CABP in both the hospital and community settings.
