Cempra Clears Hurdle Toward FDA Approval

Chapel Hill-based drug developer Cempra has cleared a major hurdle toward FDA approval of an experimental drug that could work toward solving one of the biggest health issues worldwide.

Jason deBruyn, with the Triangle Business Journal, says the drug would work to treat one of the most commonly diagnosed bacterial infections in the world.

“[The treatment is] specifically for Community Acquired Bacterial Pneumonia,” he says. “It’s actually the number one cause of death from infection.”

deBruyn says this condition is diagnosed in 5 to 10 million new cases every year.

“It’s developed some antibiotic resistance,” he says. “The Center for Disease Control and Prevention and the World Health Organization have cited antibiotic resistance as the number one problem facing the world on a health care basis.”

deBruyn says the experimental drug has cleared one phase three trial, which is required to receive approval from the Food and Drug Administration.

He says positive phase three results mean the drug has made progress in treating a human subject with the disease. Cempra has another phase three trial underway currently.

If Cempra does receive approval, the Chapel Hill-based drug developer will likely hope this medication would serve as treatment for many other infections, according to deBruyn.

“If they receive approval from the FDA for their drug to treat that disease,” he says, “it’s very common for drug developers to see what else this could fight.”

Cempra is attempting to raise $140 million through stock offerings to continue funding their research.

deBruyn says approval from the FDA could still be more than a year away.