Phase III data on Solitaire (solithromycin oral capsules) in community-acquired bacterial pneumonia- Cempra

Cempra has announced the publication of positive results from its pivotal Phase III clinical trial of Solitaire (solithromycin oral capsules) in the treatment of patients with community-acquired bacterial pneumonia (CABP) in The Lancet Infectious Diseases. Solithromycin met the primary objective of statistical non-inferiority to oral moxifloxacin for the treatment of CABP with a treatment success rate at the early clinical response (ECR, 72 hours after the first dose of study drug) of 78.2% for solithromycin and 77.9% for moxifloxacin. The 95% confidence interval for the treatment difference had lower and upper bounds of -5.5% and 6.1%, respectively. Treatment emergent adverse events were comparable for the two patient groups with 155 (36.6%) reported for solithromycin and 154 (35.6%) for moxifloxacin. There were no serious adverse events attributed to solithromycin.