Cempra Announces Positive Phase 3 Results For Oral Solithromycin To Treat CABP

(RTTNews) - Cempra Inc. (CEMP) announced positive topline results from a global, pivotal Phase 3 clinical trial of solithromycin oral capsules or Solitaire-Oral in the treatment of patients with community acquired bacterial pneumonia or CABP.

In the intent-to-treat population (ITT, all randomized patients), solithromycin met the primary objective of statistical non-inferiority (10% non-inferiority margin) of the early clinical response at 72 (-12/+36) hours after initiation of therapy compared to moxifloxacin.

The company stated that Solithromycin also met the secondary objectives of non-inferiority in clinical success at the short term follow up (SFU) visit, 5-10 days after the end of therapy, both in the ITT and clinically evaluable populations.

The point estimates for the primary endpoint of early clinical response were 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.

The results were similar in the combined total patient population, however, initial sub-groups analysis by age, indicate that the difference in point estimates became larger with increasing age and favored solithromycin in the ITT early clinical response groups. The results for the secondary efficacy endpoints supported results from the primary endpoint.

Community-acquired bacterial pneumonia is the number one cause of death from an infection, particularly in the very young and old. CABP is one of the most commonly diagnosed bacterial infections in the U.S. resulting in five to 10 million cases per year. Although many strains of Streptococcus pneumoniae, (the primary CABP pathogen) are resistant to currently-approved macrolides, this class of antibiotic remains among the most commonly prescribed class of antibacterial drugs for CABP both in the hospital and community settings.