Cempra sags after reporting Solithera setbacks
Cempra Inc. (NASDAQ:CEMP) lost $0.80 (19%) to $3.40 after reporting a pair of setbacks for antibiotic candidate Solithera solithromycin. The company said the candidate failed to show non-inferiority to standard of care (SOC) in the Phase III SOLITAIRE-U trial to treat gonorrhea. Cempra also suspended Solithra's development to treat non-alcoholic steatohepatitis (NASH). The company plans to restructure and reduce headcount by 91 employees (67%) to 45.
In SOLITAIRE-U's microbiological intent-to-treat (mITT) population, Solithera led to an 80.5% success rate vs. 84.5% for intramuscular ceftriaxone and oral azithromycin. Success was defined as a negative urethral or cervical swab culture at day seven to eight after treatment. Cempra said the number of failures in the trial was most likely related to the duration of treatment...
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