Cempra (CEMP) Announces Interim Solithromycin Phase 2 Data in NASH; NAFLD NAS, ALT Reductions Noted

September 29, 2016 4:17 PM EDT

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Cempra, Inc. (Nasdaq: CEMP) announced interim results showing anti-NASH effects in the first six nonalcoholic steatohepatitis (NASH) patients dosed with solithromycin in a Phase 2 study.

Compared with baseline values, after 90 days of solithromycin treatment, all six NASH patients had a reduction in their nonalcoholic fatty liver disease (NAFLD) activity score (NAS) (mean reduction, 1.3) and their alanine aminotransferase (ALT) (mean reduction, 17.8 U/L). Five of six patients had a reduction in their aspartate aminotransferase (AST), and the sixth patient had an AST that was unchanged and normal (mean reduction for the six patients, 10.1 U/L).

There were also mean reductions in ballooning hepatocyte degeneration and inflammation, both of which are histological signs of NASH.

Solithromycin has been well tolerated in this study.

According to the National Institutes of Health, up to 16 million Americans, or two to five percent of the U.S. population, has NASH.

“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 Pierre Gholam, M.D., 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,” Gholam added.

Based on the safety profile and activity seen in the first six patients, Cempra plans to continue the Phase 2 study to obtain data from up to 15 NASH patients. Enrollment is expected to complete in the first quarter of 2017.

“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 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 2014, Cempra announced that solithromycin significantly lowered NAFLD activity scores by affecting ballooning degeneration, gluconeogenesis and inflammation in an animal model of NASH (http://scientonline.org/fulltext/solithromycin-diminishes-steatohepatitis-by-modulating-gluconeogenesis-and-inhibits-tumor-growth-in-a-diabetic-mouse-model-of-non-alcoholic-steatohepatitis/21298).

In early 2016, Cempra dosed the first patient in this Phase 2 study and announced that the company planned to conduct an interim analysis of the results, as announced today, approximately halfway through study enrollment in order to assess clinical safety and benefit.

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