Pneumonia drug garners favorable results in study

February 16, 2016

A treatment for community-acquired bacterial pneumonia (CABP) garnered comparable results to moxifloxacin in a newly published late-phase study.

A treatment for community-acquired bacterial pneumonia (CABP) garnered comparable results to moxifloxacin in a newly published late-phase study.

Positive results from a phase 3 clinical trial of solithromycin oral capsules (Cempra) were published in the February 4 online edition of The Lancet Infectious Diseases. Notably, solithromycin is a highly potent next-generation macrolide, the first fluoroketolide, which has activity against the common CABP pathogens and macrolide-resistant bacterial strains.

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"Pneumonia remains a top ten cause of death in the U.S. and is the leading cause of death from infectious disease in most developed countries. The management of CABP is challenged by increasing antimicrobial resistance, which is approaching 50% in the U.S.," said Carlos M. Barrera, MD, 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." 

In the intent-to-treat population of this study, 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.

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Treatment-emergent adverse events were comparable for the 2 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 2 cases of Clostridium difficile infection, both of which occurred in the moxifloxacin group.

Cempra is planning to complete a rolling New Drug Application (NDA) submission to FDA for the oral and intravenous formulations for the treatment of CABP during the first half of this year.

Already, FDA has granted fast-track designation for solithromycin IV and capsules for the treatment of CABP and has designated solithromycin IV and capsules for the treatment of CABP as a Qualified Infectious Disease Product (QIDP).

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