Intercept Pharmaceuticals, Inc. (NASDAQ:ICPT) dosed first patient in a Phase 2 study evaluating a fixed-dose combination of obeticholic acid (OCA) and bezafibrate (BZF) for the treatment of patients with primary biliary cholangitis (PBC).
The study is expected to recruit approximately 60 patients in the United States.
Further, a second Phase 2 study is currently active in Europe, evaluating different dosing regimens of the OCA-BZF combination.
M. Michelle Berrey, Chief Medical Officer, said, ”We believe OCA and BZF have synergistic mechanisms of action that can potentially provide additional benefits to people with PBC when used in combination. Additionally, both medicines have been shown to help lower the key biochemical measures that predict long-term outcomes in PBC. BZF has also been associated with improvements in pruritus, a potential benefit we are exploring in our Phase 2 program.”
In the on-going phase 1 study in the United States, healthy adult subjects are being tested for different dosage combinations.
Intercept Pharmaceuticals is currently trading down at $18.58.