Cempra Slips on Phase 3 Results

In the intent-to-treat population, solithromycin met the FDA primary objective of statistical non-inferiority compared to moxifloxacin at the early clinical response.

Solithromycin also met the co-primary objective of statistical NI compared to moxifloxacin at the ECR in the microbiological ITT (mITT) population (those patients with an etiologic diagnosis of the cause of CABP) from the pooled data from both Phase 3 studies.

The FDA has granted Fast Track designation for solithromycin IV and capsules for the treatment of CABP. The agency has also designated solithromycin IV and capsules for the treatment of CABP and solithromycin capsules for the treatment of gonorrhea as a Qualified Infectious Disease Product (QIDP).

Prabhavathi Fernandes, Ph.D., president and CEO of Cempra, said:

The positive results of our solithromycin Phase 3 program in the treatment of CABP, first using oral capsules and now with the IV formulation, which included a switch to oral capsules, are a remarkable achievement for Cempra. I would like to express my sincere gratitude to all of the patients and physicians that participated in these important studies. The ability to treat patients in the hospital with solithromycin IV and switch them to an oral formulation of the same antibiotic may allow for earlier patient discharge from the hospital and result in cost savings. We believe that solithromycin’s potency, spectrum, safety and efficacy could provide a new antibiotic treatment option that is urgently needed to offset the rising problem of bacterial resistance. I am delighted to announce that we will now be moving forward with solithromycin’s NDA submission to the FDA for the treatment of CABP, which we expect to complete during the first half of 2016.

Shares of Cempra were last seen trading down more than 32% at $18.03, with a consensus analyst price target of $47.64 and a 52-week trading range of $11.35 to $46.99.

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