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>>> Cempra tumbles on safety concerns of anti-bacterial drug


Oct 16, 2015


http://www.reuters.com/article/us-cempra-study-idUSKCN0SA1E420151016



By Natalie Grover

Cempra Inc stock plunged 37 percent on Friday over potential safety concerns related to the company's drug to treat a common bacterial infection that met its main goal in a late-stage study.

The company said while increased levels of liver enzymes were seen across treatment arms, the magnitude was higher in those who received its drug, solithromycin.

Patients in the second late-stage trial initially received IV administration of either solithromycin or Bayer AG's moxifloxacin, following which they could switch over to the oral version of their assigned drugs if deemed stable.

Concerns about the drug's safety, including liver toxicity and infusion-associated heart rate elevations, have tempered enthusiasm, Morgan Stanley's Andrew Berens said.

Data announced from the first late-stage study in January showed that the oral version of the drug was successful in patients with community-acquired bacterial pneumonia (CAPB).

"...The (second late-stage) trial failed to reaffirm the superiority seen in the elderly patient population during the oral trial, a potential commercial niche for the drug," Berens wrote in a note.

With about 5-10 million annual cases in the United States, CAPB is the leading cause of death due to an infection and is characterized by shortness of breath, cough and fever.

Solithromycin is a next-generation version of a class of oft-prescribed antibiotics called macrolides, which are used to fight pathogens that cause CAPB.

Solithromycin was found to be as effective as moxifloxacin — the study's main goal.

WBB Securities' Stephen Brozak said the trial was unequivocally successful in the face of rampant macrolide resistance.

"You certainly don't see success like this in antibiotic development and that's what people should understand", he said.

Prior-generation macrolides, including Sanofi SA's telithromycin and Pfizer Inc's azithromycin, have triggered safety concerns in the past.

While telithromycin was associated with liver toxicity, azithromycin has been linked with heart risk.

Cempra said it expects to complete submitting a U.S. marketing application as a treatment for CAPB in the first half of next year.

The drug is also being tested in pediatric population, as well as being evaluated for use in uncomplicated gonorrhea and chlamydia infections.

The company's shares were down 34.3 percent at $17.59 in mid-day trading.

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