CEM-101, an oral new generation macrolide antibiotic developed by Cempra Pharmaceuticals, will soon go on clinical studies to establish the drug’s efficacy as as intravenous formulation.
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.
Phase 1 clinical trials of its oral formulation of CEM-101 has shown good tolerability, Cempra said in a press statement.
Cempra is planning to submit an investigational new drug application (IND) to US FDA to begin a phase 1 study with the company’s intravenous formulation of CEM-101 in mid-2010.
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).
“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,” stated J. Carl Craft, M.D., head of medical affairs, Cempra Pharmaceuticals, and a member of Cempra’s Scientific Advisory Board.
Cempra expects to start phase 2 studies in patients with moderate to moderately severe community-acquired bacterial pneumonia in the coming months, he said.
Cempra will present full details of the phase 1 studies at the upcoming European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) on April 10 to 13 in Vienna, Austria.
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, according to company officials.
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).
CEM-101 showed potent activity, in vitro and in vivo, against all important respiratory pathogens, including pneumococci, as well as potent activity against a
broad spectrum of other serious pathogens including CA-MRSA, M. avium, malaria, atypical bacteria such as legionella, mycoplasma, chlamydophila, and against gonococci.
CEM-101 is generally 8 to 16 times more potent than azithromycin and is active against organisms that have become resistant to azithromycin.
Over 5 million patients get pneumonia in the United States is each year.
Cempra has licensed exclusive worldwide rights from Optimer Pharmaceuticals, Inc., except in the Association of Southeast Asian Nations (ASEAN) countries, to discover, develop and commercialize macrolides from a library of more than 500 compounds from Optimer’s OPopS drug discovery platform.
Cempra Pharmaceuticals is a privately-held, clinical-stage pharmaceutical company focused on developing antibacterials.
The company is also utilizing its proprietary compound library and chemistry technology to develop novel macrolides without antibacterial activity for non-antibiotic uses such as COPD, chronic inflammatory and GI disorders.