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 Medicineand 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. (Original Source)
Shares of Cempra closed today at $23.88, down $2.34 or -8.92%. CEMP has a 1-year high of $34.79 and a 1-year low of $14.03. The stock’s 50-day moving average is $23.27 and its 200-day moving average is $19.17.
On the ratings front, CEMP stock has been the subject of a number of recent research reports. In a report issued on September 13, Raymond James analyst Christopher Raymond initiated coverage with a Buy rating on CEMP and a price target of $32, which implies an upside of 21.5% from current levels. Separately, on August 2, Baird’s Brian Skorney reiterated a Buy rating on the stock and has a price target of $33.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Christopher Raymond and Brian Skorney have a total average return of 38.9% and 20.5% respectively. Raymond has a success rate of 78% and is ranked #49 out of 4181 analysts, while Skorney has a success rate of 58% and is ranked #76.
Overall, 9 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $38.57 which is 46% above where the stock opened today.
Cempra, Inc. engages as a clinical-stage pharmaceutical company, which focuses on the development of antibacterials to meet critical medical needs. Its antibiotic candidates includs Solithromycin and Taksta.