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Cempra soars as oral antibiotic Solithromycin fares well in phase 3 clinical testing

Last updated: 07:54 05 Jan 2015 EST, First published: 08:54 05 Jan 2015 EST

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Cempra (NASDAQ:CEMP) surged in premarket trades after the clinical-stage pharmaceutical company its treatment for patients with a common form of pneumonia, solithromycin, fared well in late-stage clinical testing.

Shares rose as much as 16 percent at $26.58 at 8:25 a.m. in New York today. The stock had rallied 75 percent over the past year through Jan. 2.

Solithromycin capsules proved to be not inferior to a competing treatment, Bayer AG’s (OTCMKTS:BAYRY) moxifloxacin, when given to patients with community-acquired bacterial pneumonia CABP, according to early results from the study, the Chapel Hill, North Carolina-based company said in a statement yesterday.

Solithromycin is a next-generation version of a class of oft-prescribed antibiotics called macrolides, which are used to fight pathogens that cause CAPB, which is, in turn, the leading cause of death emanating from an infection and is characterized by shortness of breath, cough and fever.

In the intent-to-treat population (ITT, all randomized patients), solithromycin met the primary objective of statistical non-inferiority (10 percent non-inferiority margin) of the early clinical response at 72 (-12/+36) hours after initiation of therapy compared to moxifloxacin.

Cempra said Solithromycin also met the secondary objectives of non-inferiority in clinical success at the short term follow up (SFU) visit, 5-10 days after the end of therapy, both in the ITT and clinically evaluable populations.

The point estimates for the primary endpoint of early clinical response were 78.2 percent for solithromycin and 77.9 percent for moxifloxacin.

"I congratulate Dr. David Oldach, senior vice president of Clinical Research, his clinical group and the entire Cempra team for running this landmark oral study which has produced these positive efficacy results for the Solitaire-Oral clinical trial, the first of our two pivotal Phase 3 studies for solithromycin," the company’s chief executive officer, Prabhavathi Fernandes, said in the statement.

"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. Our Phase 3 Solitaire intravenous study continues to enroll patients as planned."

 

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