Intercept Pharmaceuticals news concerning the results from a Phase 3 clinical trial have ICPT stock up today.
The good news for Intercept Pharmaceuticals (NASDAQ:ICPT) is that the company’s Phase 3 Regenerate study was able to reach one of its primary endpoints. Two primary endpoints were set, but only one needs to be met for the study to be a success.
The Intercept Pharmaceuticals news includes the Phase 3 study meeting the primary endpoint of obeticholic acid causing “fibrosis improvement (≥1 stage) with no worsening of nonalcoholic steatohepatitis (NASH).” This was for the 25 mg dose of obeticholic acid.
The second primary endpoint that was not met in the recent Phase 3 clinical trial was NASH resolution with no worsening of liver fibrosis. The company says a number of patients reached this endpoint, but that it wasn’t of statistical significance.
According to the Intercept Pharmaceuticals news release concerning the results of the study, this opens the way for a submission to the U.S. Food and Drug Administration and European regulators. The company says that it is intending to make this submission in the second half of 2019.
“We are thrilled to report the first positive registrational Phase 3 study results in patients with NASH,” Mark Pruzanski, M.D., President and CEO of Intercept Pharmaceuticals, said in a statement. “The topline REGENERATE data we are reporting today support our belief that OCA will become the first approved medicine for those living with liver fibrosis due to NASH.”
ICPT stock was up 7% as of Monday afternoon.
As of this writing, William White did not hold a position in any of the aforementioned securities.