Cempra shares soar on success of a head-to-head PhIII antibiotic study

Shares of Cempra ($CEMP) shot up more than 30% in premarket trading on Monday as investors digested news of a promising outcome for its head-to-head study of its lead antibiotic solithromycin.

Investigators for the Chapel Hill, NC-based biotech reported that the oral antibiotic hit the mark for noninferiority to moxifloxacin 72 hours after beginning treatment among patients with community-acquired bacterial pneumonia, or CABP. And they hit their secondary endpoint for noninferiority during a short-term follow-up visit 5 to 10 days after treatment.

"The management of CABP remains a challenge for healthcare providers and I believe solithromycin has the potential to be a rational option for the treatment of this life threatening illness," said Cempra CEO Prabhavathi Fernandes in a statement. "Our Phase III Solitaire intravenous study continues to enroll patients as planned."

Cempra is one of a group of biotechs which persevered at developing new antibiotics long after Big Pharma had been turned away the field by lean margins and poor market prospects. The trend against antibiotic development has been creating serious problems for patients, as immunity to older antibiotics builds up over time. But Merck ($MRK) recently jumped back into the field with its proposed acquisition of Cubist ($CBST), and Roche's ($RHHBY) pRED group based in Basel has inked a slate of new development deals.

Investigators recruited 860 patients for this study, starting off the solithromycin group with an 800 mg dose followed by 400 mg daily for 5 days. The moxifloxacin arm received 400 mg a day for 7 days. The adverse event profile looked similar in both arms, according to Cempra.

Cempra shares were trading north of $29 this morning.

- here's the release

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