Cempra Inc moved a step closer to approval of its lead antibiotic after the potential blockbuster was successful in a second late-stage trial in patients with a common bacterial infection.

Data announced in January had showed that the oral version of the drug was successful in a separate late-stage study in patients with community-acquired bacterial pneumonia (CAPB).

The drug, solithromycin, is a next-generation version of a class of oft-prescribed antibiotics called macrolides, which are used to fight pathogens that cause CAPB.

Patients in this trial initially received IV administration of either solithromycin or Bayer AG’s moxifloxacin, following which they could switch over to the oral version of their assigned drugs if deemed stable.

Solithromycin was found to be as effective as moxifloxacin — the study’s main goal.

CAPB is the leading cause of death emanating from an infection and is characterized by shortness of breath, cough and fever, with about 5-10 million cases in the United States per year.

 

 

(Reporting by Natalie Grover in Bengaluru; Editing by Don Sebastian)

Source: Reuters Health

http://www.reuters.com/article/2015/10/16/us-cempra-study-idUSKCN0SA1E420151016