Cempra, Inc. last week announced its global Phase 3 clinical trial of orally administered solithromycin (CEM-101) in patients with community-acquired bacterial pneumonia (CABP). The company expects the trial to be complete in the first half of 2014.
The double-blind, placebo-controlled and global multi-center Phase 3 study will randomize approximately 800 patients with PORT-II to PORT-IV CABP to receive either oral solithromycin, an 800 mg loading dose followed by 400 mg once daily for a total of five days, or once-daily oral administration of 400 mg of moxifloxicin for seven days. The primary endpoint will be non-inferiority of early response at 72 hours, which is specified by the proposed FDA guidance.
Solithromycin, the company’s fluoroketolide antibiotic candidate, has shown a favorable safety profile in over 400 patients including when compared to levofloxacin in a Phase 2 trial in CABP patients, according to the company.
“The compound may offer both flexibility and convenience as it is in development for both oral and intravenous formulations,” according to Cempra. “In addition, and as this clinical trial may demonstrate, patients may be able to avoid hospital admission by starting on the oral form as monotherapy.”