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news.Cempra Pharma, a privately-held, clinical-stage pharmaceutical firm focused on developing antibacterials, has completed Phase 1 clinical trials of its oral formulation of CEM-101 and also revealed its plans to submit an IND to the FDA to begin a Phase1 study with its intravenous formulation of CEM-101 in mid-2010.
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According to Cempra Pharma, CEM-101 is expected to be the first macrolide to have an intravenous formulation available in the US since intravenous azithromycin was approved in 1997, a major development that carves a path for studies in moderate to severe community-acquired bacterial pneumonia (CABP).
Cempra Pharma claimed that CEM-101 is a next-generation macrolide with potent activity against pneumococci, including macrolide- and quinolone-resistant strains. The company said that 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).
J Carl Craft, head of medical affairs at Cempra Pharma and a member of scientific advisory board, said: “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. 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, president and CEO of Cempra, said: “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.”