Cempra Pharmaceuticals has initiated two studies of solithromycin for the treatment of community-acquired bacterial pneumonia (CABP).
Solithromycin is a fluoroketolide with potent in-vitro activity against respiratory pathogens such as pneumococci.
The first study is a Phase I, randomised, double-blind and multi-centre trail to compare the safety and efficacy of oral solithromycin versus levofloxacin. It will involve 150 patients with moderate-to-moderately severe CABP.
The second study is a Phase II, multiple-dose escalating study trial to evaluate the safety, tolerability and pharmacokinetics of intravenous solithromycin in healthy adults.
Results from both studies are expected in the first quarter of 2011.
CABP affects about five million people in the US annually, and causes one million to be hospitalised.