- Intercept Pharmaceuticals focuses on developing treatments for chronic liver and intestinal diseases.
- Intercept is currently focusing on the development of obetocholic acid (OCA) for treating nonalcoholic steatohepatitis (NASH).
- The phase III study evaluating OCA -- the FLINT study -- was halted in mid-January after researchers determined the drug to be effective. More research results are needed before Intercept applies for FDA approval.
The stock market’s response to the study has been extremely positive in light of OCA's efficacy and safety outcomes. In the FLINT trial, 22% of OCA-treated patients had a NASH resolution, versus 13% of placebo-treated patients. However, the results were not deemed statistically significant.
In addition, 35% of OCA-treated patients had an improvement in fibrosis, versus 19% of placebo-treated patients. Another positive: Safety outcomes were solid. Researchers previously worried there might be cardiovascular safety issues associated with OCA, but they have determined that those events were unrelated to treatment with the drug. Approval is still a ways off as additional data still needs to be made public; nonetheless, analysts are bullish on Intercept and this drug.