Cempra on Friday announced positive results in the first six nonalcoholic steatohepatitis patients dosed with solithromycin in a Phase 2 study, according to a filing with the Securities and Exchange commission.
The target disease of the drug is known as NASH and occurs in approximately 10 to 20 percent of patients with nonalcoholic fatty liver disease, according to the company.
NASH is a progressive form of live disease where accumulation of excessive fat coexists with liver cell injury, inflammation and fibrosis, which eventually leads to liver cancer in a subset of patients.
NASH affects between 2 percent and 5 percent of the U.S. population, and there are no approved drugs for this condition. In the absence of proven treatment, physicians often recommend a combination of diet and exercise.
“We are very excited to see that these early clinical results with solithromycin in NASH patients are confirming the results we saw in our preclinical studies and we look forward to continuing to investigate this important unmet medical need,” said Prabhavathi Fernandes, Ph.D., president and chief executive officer of Cempra in a statement.
Cempra is a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases and was founded in 2006.
The company’s lead product candidate, Solithromycin, is currently in advanced clinical development. It has been successfully evaluated in two Phase 3 clinical trials for community acquired bacterial pneumonia and is expected to reach Food and Drug Administration approval by the end of 2016.
Note: This story is from the North Carolina Business News Wire, a service of UNC-Chapel Hill’s School of Media and Journalism
