Cempra Inc. Presents Full Data Set Of Phase 2 Clinical Trial Of CEM-101 (Solithromycin) In Community-Acquired Bacterial Pneumonia Patients At The European Congress Of Clinical Microbiology And Infectious Diseases (ECCMID)
CHAPEL HILL, N.C., March 31, 2012 /PRNewswire/ -- Cempra Inc. (Nasdaq: CEMP), a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases,today announced that data will be presented at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), in London, March 31 to April 3,demonstrating CEM-101's (solithromycin's) efficacy to be comparable to levofloxacin in a Phase 2 trial of patients with community-acquired bacterial infections (CABP). The study also demonstrates solithromycin's favorable safety and tolerability profile compared to levofloxacin. "This is the first time that the full data set of this Phase 2 trial has been available for review by the infectious disease community," said Prabhavathi Fernandes, chief executive officer of Cempra. "The promising results of this clinical trial will now be the basis for the initiation of our Phase 3 program in CABP. We expect to begin the first Phase 3 trial evaluating oral solithromycin in moderate-to-moderately severe CABP patients in the second half of 2012. Additionally, we are planning Phase 3 trials for 2013 testing the efficacy of intravenous-to-oral step down administration of solithromycin in moderate-to-severe CABP." CABP is the number one cause of death due to bacterial infection in the U.S. There are over five million cases per year resulting in about one million hospitalizations per year. Macrolide antibiotics, such as azithromycin (52 million prescriptions in 2010), have been the mainstay of respiratory tract infection treatment but bacterial resistance has been increasing to as high as 30 percent of pneumococcal isolates in the United States. New antibiotics are needed to confront this rising public health issue. Oldach et al., ( Abst. # P719; 3:30 to 4:30 p.m. BST, Saturday, March 31) conducted a multi-center, double-blind, randomized Phase 2 clinical trial to evaluate oral solithromycin versus oral levofloxacin in the treatment of adults with moderate to moderately-severe CABP. One-hundred-thirty-two patients were randomized to receive either solithromycin (800 mg on day one followed by 400 mg on days two to five) or levofloxacin (750 mg on days one through five). The primary outcome measure was investigator's assessment of clinical success at test-of-cure (TOC; four to 11 days after the last dose of study drug) in the intent-to-treat (ITT) and clinically-evaluable (CE) populations. Early response to treatment (at day three) was defined as improvement in at least two symptoms (cough, sputum production, chest pain, dyspnea) without worsening in any. Clinical success rates for solithromycin, compared to levofloxacin, were comparable across endpoints (TOC both ITT and CE, day three ITT and microbiological ITT). Solithromycin-treated patients experienced fewer treatment-emergent adverse events (29.7%) than levofloxacin-treated patients (45.6%). No patients on solithromycin discontinued treatment due to an adverse event whereas six patients on levofloxacin discontinued treatment due to an adverse event. Solithromycin demonstrated efficacy comparable to levofloxacin with a favorable safety and tolerability profile that showed fewer treatment-emergent adverse events than levofloxacin.