PREFACE
Cempra Inc. (NASDAQ:CEMP) is one of the most exciting young biotech companies and while the company already has the data it needs to file for FDA approval for one of its treatments, the company got more good news today.
STORY
We just added Cempra Inc. (NASDAQ:CEMP) to our Top Picks list this week and we got good news right away. If we turn back to the Top Pick dossier we can see that Cempra has a long list of possible uses for its drug treatments. One the largest ones we did not discuss is all of a sudden front and center after preliminary results for a Phase II study were released. Here are some snippets with our own emphasis added:
"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).
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, so this is a massive patient group that Cempra is looking to treat. 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.
Pierre Gholam, M.D., from Case Western Reserve University School of Medicine and principal investigator of the study had this to say:
"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.
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."
What This Means
In English, this is yet another successful interim study for Cempra Inc. (NASDAQ:CEMP) that has the potential to be a blockbuster. News like this might act as a buffer for the stock price if the company gets bad news when it has its Advisory Committee (AdCom) with the FDA in early November and then gets its FDA decision on December 27th and December 28th for its other treatments.
Cempra exemplifies the traits we look for in a Top Pick -- broad based exposure to a booming thematic shift -- in this case antibiotic resistance, a phenomenon that the United Nations just declared "the greatest and most urgent global risk" in its meeting on September 21st. The stock will gyrate, often time for seemingly (and literally) no reason. Focus on the big announcements, which we will alert you to.
In sum, this is more very good news for Cempra Inc. (NASDAQ:CEMP).
The author has a long position in Cempra Inc. (NASDAQ:CEMP).
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