Cempra meets Phase III endpoint, sinks on safety concerns

Cempra Inc. (NASDAQ:CEMP) fell $7.49 (28%) to $19.29 on Friday after reporting data from the Phase III Solitaire-IV study of IV solithromycin ( CEM-101) to treat community-acquired bacterial pneumonia (CABP). Cempra said solithromycin met all primary objectives in the study to support a planned FDA submission, but reported more treatment-related AEs and greater alanine aminotransferase (ALT) elevations in patients receiving solithromycin compared with patients receiving comparator drug moxifloxacin.

Cempra said solithromycin met the FDA primary objective of non-inferiority to moxifloxacin within a 10% margin at early clinical response (ECR) in the intent-to-treat (ITT) population (79.3% solithromycin vs. 79.7% moxifloxacin; 95% CI: -6.1%, 5.2%). It also was non-inferior in moxifloxacin at ECR in the microbiological ITT population in pooled data from two Phase III studies, a co-primary objective (77.2% solithromycin, 78.9% moxifloxacin; 95% CI: -7.4%, 4.2%). ...