Drug news
CEM-101 (Cempra) success in Phase II trial for CABP
Cempra Inc. 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 II trial of patients with Community-Acquired Bacterial Infections (CABP). The study also demonstrates solithromycin's favorable safety and tolerability profile compared to levofloxacin.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 Cempra plan to begin the first Phase III trial evaluating oral solithromycin in moderate-to-moderately severe CABP patients in the second half of 2012.see Oldach et al., (Abst. # P719; 3:30 to 4:30 p.m. BST, Saturday, March 31)