Cempra, Inc. (CEMP) announced positive top-line results from a global, phase III study on pipeline candidate solithromycin. Cempra is evaluating solithromycin for the treatment of community-acquired bacterial pneumonia (CABP).
Results of the trial showed that oral capsules of solithromycin met the primary objective of statistical non-inferiority (10% non-inferiority margin) of the early clinical response at 72 (-12/+36) hours after initiation of therapy when compared to moxifloxacin among randomized patients. The point estimates for the primary endpoint of early clinical response were 78.2% for solithromycin and 77.9% for moxifloxacin.
Additionally, solithromycin met the secondary objectives of non-inferiority in clinical success at the short-term follow-up visit, 5-10 days after the end of therapy among both randomized and clinically evaluable populations.
Although the results were similar in the total patient population, the difference in point estimates increased in initial sub-groups (on an age basis) with increasing age and favored solithromycin in the randomized, early clinical response.
We note that the study was the first to be completed under the proposed FDA CABP guidance wherein the new primary endpoint of the early clinical response will be assessed in the pooled mITT population (intent to treat population with microbial isolates) across two similar phase III trials, utilizing a 12.5% non-inferiority margin.
Cempra expects to present additional data from the trial in upcoming scientific meetings.
Meanwhile, a second phase III trial on the intravenous formulation of solithromycin is currently enrolling patients.
We note that Cempra is developing another candidate, Taksta, for the treatment of patients with prosthetic joint infections.
Going forward, we expect investor focus on further pipeline updates as Cempra does not have any approved product in its portfolio.
Cempra carries a Zacks Rank #3 (Hold). Some better-ranked companies in the health care sector include Sucampo Pharmaceuticals (SCMP), Biodel Inc. (BIOD) and Lannett Inc. (LCI). All three carry a Zacks Rank #1 (Strong Buy).
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