Cempra, Inc. CEMP announced positive top-line results from a global, phase III study (Solitaire-IV) on pipeline candidate intravenous (IV) to oral solithromycin. Cempra is evaluating solithromycin for the treatment of community-acquired bacterial pneumonia (CABP).
In the study, solithromycin met the primary objective of statistical non-inferiority compared to moxifloxacin at the early clinical response in the intent-to-treat population. The point estimates for early clinical response were 79.3% for solithromycin and 79.7% for moxifloxacin.
Solithromycin also met the co-primary objective of statistical non-inferiority compared to moxifloxacin at the early clinical response in the microbiological intent-to-treat population from the pooled data from both phase III studies.
The FDA has granted Fast Track designation and Qualified Infectious Disease Product (QIDP) status to solithromycin (IV and capsules) for the treatment of CABP. The agency has also designated solithromycin capsules for the treatment of gonorrhea as QIDP.
Based on encouraging phase III study data, the company plans to start submitting a rolling new drug application for solithromycin for the treatment of CABP by the end of this year and complete the submission by the first half of 2016.
However, treatment-related adverse events were higher in the solithromycin (34.3%) arm as compared to moxifloxacin (13.1%).
Going forward, we expect investor focus on further pipeline updates as Cempra does not have any approved product in its portfolio. Currently, the CABP market has the presence of companies like Pfizer PFE, Allergan AGN and Bayer BAYRY.
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