Cempra, Inc., a clinical-stage pharmaceutical company focused on developing antibiotics, announced on Feb. 5 the publication of positive results from its pivotal Phase 3 clinical trial of solithromycin oral capsules in the treatment of patients with community-acquired bacterial pneumonia (CABP).
The article, titled, “Efficacy and safety of oral solithromycin versus oral moxifloxacin for the treatment of community-acquired bacterial pneumonia: a global, double-blind, multi-centre, randomized, active-controlled, non-inferiority trial (SOLITAIRE-ORAL)” appears in The Lancet Infectious Diseases.
“The management of CABP is challenged by increasing antimicrobial resistance, which is approaching 50 percent in the U.S.,” said Carlos M. Barrera, M.D., principal investigator and a pulmonologist and endocrinologist at Baptist Hospital of Miami. “The results of this study are exciting because solithromycin demonstrated efficacy comparable to moxifloxacin, with a safety profile similar to the most widely-used macrolide antibiotics. This shows the potential to restore the use of macrolide monotherapy for CABP.”
Solithromycin is a highly potent next-generation macrolide, the first fluoroketolide, which has activity against the common CABP pathogens and macrolide-resistant bacterial strains. In the intent-to-treat population of this study (ITT, all randomized patients), 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. In addition, there were two cases of Clostridium difficile infection, both of which occurred in the moxifloxacin group.
“SOLITAIRE-ORAL is a landmark study and a significant achievement, as solithromycin is the first new oral CABP drug studied in a global, pivotal Phase 3 study in more than a decade,” stated Prabhavathi Fernandes, Ph.D., president and chief executive officer of Cempra. “We are extremely pleased that The Lancet Infectious Diseases has chosen to publish these data in their journal.”
In October, Cempra announced successful results of the second Phase 3 pivotal trial of solithromycin that used an intravenous formulation (Solitaire-IV), and has begun and is planning to complete a rolling New Drug Application (NDA) submission to the FDA for the oral and intravenous formulations for the treatment of CABP during the first half of 2016.
The FDA has granted Fast Track designation for solithromycin IV and capsules for the treatment of CABP. The Agency has also designated solithromycin IV and capsules for the treatment of CABP as a Qualified Infectious Disease Product (QIDP).
