Immuron Limited released preliminary results from its IMM-124E phase II study of nonalcoholic steatohepatitis patients.
Researchers studied 133 nonalcoholic steatohepatitis patients for its phase II trial. Top-line results are expected in the fourth quarter of fiscal year 2017.
Researchers studied patients who received either a 600 mg, a 1,200 mg dose of IMM-124E or a placebo.
Here's what you should know:
1. Researchers determined the IMM-124E group was safe and well tolerated when compared to the placebo group.
2. Researchers noted significant changes in alanine aminotransferase liver enzymes in the IMM-124E and placebo treatment groups. There was no statistical difference in effectiveness between either of the three groups.
3. There was a positive trend concerning the 1,200 mg group after researchers corrected for baseline values.
4. Researchers determined there was no difference between the groups in hepatic at fraction, the study's primary endpoint. Immuron wrote this off as small sample size.
Researchers concluded, "Early biochemical improvements in liver enzymes are noted, suggesting potential therapeutic benefit for treatment of [nonalcoholic steatohepatitis patients]."
The National Institutes of Health Data and Safety Monitoring Board recommended the study continue to completion.
More articles on gastroenterology:
New York hospital planning surgery center — 4 key notes
GI leader to know: Dr. D. Isaac Gaines of Gastroenterology Associates
GI center to know: Utah Gastroenterology