Solitaire-Oral(solithromycin oral) success in pivotal Phase III trial for CABP- Cempra Inc.

Cempra, Inc. has announced positive topline results from a global, pivotal Phase III clinical trial of solithromycin oral capsules (Solitaire-Oral) in the treatment of patients with Community Acquired Bacterial Pneumonia (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. 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.