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Cempra Reports Positive Data on Antibiotic Solithromycin

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Pipeline updates are highly awaited events in the pharma/biotech sector as they play an important role in deciding whether or not to invest in a particular company. These updates provide information on experimental drugs and at times give an insight into the commercial potential of the candidate once it is successfully developed and commercialized.

Last week, Cempra, Inc.CEMP announced positive results from the phase III SOLITAIRE-ORAL study on solithromycin (oral capsules) for the treatment of patients with community-acquired bacterial pneumonia (CABP). Results were published in The Lancet Infectious Diseases .

The double-blind, multi-centre, randomized, active-controlled, non-inferiority study evaluated the safety and efficacy of solithromycin, in comparison to moxifloxacin, for the treatment patients with CABP. Data from the study demonstrated that the candidate met the primary and secondary objectives of non-inferiority compared to moxifloxacin.

Cempra has begun filling a rolling New Drug Application (NDA) for both oral and intravenous formulations of solithromycin for the treatment of CABP. The rolling NDA submission is expected to be completed in the first half of 2016.

We note that solithromycin (IV and capsules) has Fast Track designation and Qualified Infectious Disease Product (QIDP) status in the U.S. for the same indication.

According to information provided by the company, CABP affects 5 to 10 million people in the U.S. each year.

Currently approved drugs for the treatment of CABP include Allergan plc's AGN Teflaro and Sanofi's SNY Tarvanic among others.

Meanwhile, solithromycin is being evaluated in a phase III study for the treatment of patients with uncomplicated urogenital urethritis caused by Neisseria gonorrhoeae or chlamydia. Cempra is also evaluating solithromycin in a phase II study for the treatment of patients with nonalcoholic steatohepatitis.

Another candidate in the company's portfolio is Taksta, which is being evaluated in a phase III study for the treatment of patients with acute bacterial skin and skin structure infections.

Cempra currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the health care sector is Ligand Pharmaceuticals Incorporated LGND , with a Zacks Rank #1 (Strong Buy).

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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