Oral Pneumonia Drug, Solithromycin, Shows Safety and Efficacy in Phase 3 Trial

Cempra announced positive results from its Phase 3 multicenter trial of oral solithromycin versus oral moxifloxacin for community-acquired bacterial pneumonia. The clinical study, which appeared in the medical journal Lancet, found solithromycin to be of similar efficacy and safety to moxifloxacin, an important finding because bacterial resistance has become an increasing problem, and new antibiotics are needed to treat infectious conditions such as pneumonia.

Solithromycin (also called CEM-101), if approved by the FDA, could be prescribed as an alternative to the β-lactam and fluoroquinolone-based medications that are commonly used. Solithromycin is what is known as a next-generation macrolide, and uses a novel mechanism to fight bacteria. Carlos M. Barrera, MD, pulmonologist and endocrinologist at South Miami Hospital of Baptist Health Miami, led the study, in collaboration with an international group of researchers.

“Pneumonia is still the number eight [cause of] mortality in the United States and other developed countries, so it’s not a small problem,” Dr. Barrera said in an interview with Infectious Disease News. “Resistance problems among antibiotics is something that is getting worse over time — it’s an inevitable process. To have a new antibiotic with no resistance … it’s an important addition to the armamentarium of the physician.”

A total of 860 adult patients with pneumonia from 114 healthcare centers worldwide participated in the trial.

Participants received either once-daily oral moxifloxacin for 7 days, or once-daily oral solithromycin for 5 days, followed by a placebo for an additional 2 days. The main study measurement was early clinical response based on pneumonia symptoms.

A total of 78.2 percent patients in the solithromycin group, and 77.9 percent patients in the moxifloxacin group, experienced early clinical response. The researchers concluded that both treatments were equally effective based on these results.

Drug safety was also similar for the two medications, with 10 percent of the solithromycin group and 13 percent of the moxifloxacin group reporting mild side effects due to medication, typically gastrointestinal problems or headache and dizziness.

One advantage of solithromycin may be that it can target a large variety of bacterial strains, according to Barrera.

“You now have available to you a monotherapy drug with a 5-day treatment that you can treat mild to severe pneumonia,” Barrera said. “A drug that has no resistance, and has such wide coverage, is a very important finding.”

The FDA gave Fast Track designation to solithromycin for community-acquired bacterial pneumonia, both an intravenous and oral form. Cempra plans to submit a New Drug Application to the FDA in early 2016, according to a company press release.

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