Antibiotics developer Cempra Inc. has released positive interim results from a Phase II clinical trial for their drug, solithromycin, in the treatment of non-alcoholic steatohepatitis (NASH). Between 10 and 20 percent of patients with nonalcoholic fatty liver disease (NAFLD) suffer from NASH, which is a progressive form of the disease characterized by excessive fat accumulation, inflammation and fibrosis.
With no known cure, NASH affects up to five percent of the US population and can progress into liver cirrhosis and potentially cancer in some patients. The growing market has attracted a handful of pharmaceutical companies looking to develop a treatment for NASH.
In a small Phase II clinical trial of six patients with NASH, solithromycin was able to reduce the NAFLD activity score (NAS) – a tool used to measure changes in the disease – by an average of 1.3. According to Cempra, the drug was well-tolerated in patients and the company plans to continue the clinical trial.
“We have been focusing on new treatments for NASH for the past 15 years and the early results we have seen with solithromycin are very promising for a patient population that urgently needs a new treatment option,” said Dr. Pierre Gholam, from Case Western Reserve University School of Medicine and principal investigator of the study. “While this is a small number of patients and further work is required to confirm these data on a wider scale, the observation that solithromycin was able to lower NAS by an average of 1.3 points in just 13 weeks with a good safety profile does allow a good measure of optimism.”
Cempra’s solithromycin is an antibacterial drug effective against most macrolide-resistant community acquired bacterial pneumonia (CABP) infections. The total course of therapy in this clinical trial was completed after just over 3 months.
“We are very excited to see that these early clinical results with solithromycin in NASH patients are confirming the results we saw in our pre-clinical studies,” said Dr. Prabhavathi Fernandes, president and chief executive officer of Cempra, “and we look forward to continuing to investigate this important unmet medical need.”
Cempra expects to complete enrollment in this study during the first quarter of 2017. Allergan is another company hoping to break into the NASH market after acquiring Akarna Therapeutics and Tobira Therapeutics last month.