Clinical-stage pharmaceutical company Cempra announced Sunday that a study involving Solitaire-Oral, solithromycin oral capsules, as treatment for community acquired bacterial pneumonia (CABP) yielded positive results.
The first to be completed using proposed CABP guidance from the U.S. Food and Drug Administration, the study showed that solithromycin produced desirable results within early clinical responses 72 hours after the antibiotic was administered compared to moxifloxacin. Short-term follow-ups were also positive, producing ideal conditions five to 10 days after treatment ended.
The study featured 860 adult patients diagnosed with moderate to moderately severe CABP, with 50 percent of subjects classified as PORT Class II patients. Who will take solithromycin and who will be given moxifloxacin were randomly chosen. Oral solithromycin was administered with a loading dose and was followed by daily doses for five days while moxifloxacin was given for seven days.
Within 72 hours, subjects showed an improvement in at least two of four symptoms associated with pneumonia: mucus production, chest pain, shortness of breath and coughing.
Side effects experienced by subjects taking solithromycin include headaches, diarrhea, nausea, emesis and dizziness. All these were also reported by subjects on moxifloxacin, but diarrhea cases were prevalent in the moxifloxacin group.
Prabhavathi Fernandes, Ph.D., chief executive officer and president of Cempra, congratulated David Oldach, Clinical Research senior vice president, his clinical group and everyone involved in Cempra for the results of the study.
"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," he added.
Solithromycin is the first fluoroketolide, a highly potent next generation of macrolides aimed at taking care of majority of macrolide-resistant strains, showing potent activity against S. pneumoniae, streptococci and Mycobacterium avium, among others. The antibiotic is able to do such by interacting with three sites on the bacteria's ribosome, also limiting resistance from developing. Current macrolides only bind to one site on bacterial ribosomes.
CABP is the top cause of death due to an infection, most especially in the very old and very young. With about five to 10 million cases are diagnosed every year, it is one of the most common bacterial infections as well. While the primary CABP pathogen is resistant to current macrolides approved for use, the antibiotic class remains one of the most prescribed for treating CABP in community and hospital settings.
