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Intercept Hopes Statin Trial Will Lessen Ocaliva's Perceived CV Risk

 
• By Joseph Haas

After otherwise successful Phase II NASH trial showed Ocaliva can increase a patient's LDL cholesterol levels, Intercept hopes a study in NASH patients who use atorvastatin will show this effect is manageable.

Liver

Intercept Pharmaceuticals Inc. is hoping that its ongoing Phase II CONTROL study will ameliorate a lingering concern about Ocaliva's prospects in non-alcoholic steatohepatitis (NASH) by showing that co-administration of a statin can manage the LDL-elevating effect seen in some patients receiving the drug.

Ocaliva (obeticholic acid/OCA), a farnesoid X receptor (FXR) agonist already approved in the US and Europe to treat primary biliary cholangitis (PBC), is one of three drug candidates to reach Phase III in NASH. Intercept was the first to start a Phase III trial and industry consensus has the company in the lead to introduce the first approved therapy for NASH, but concerns about the compound's effects on lipid levels caused concern that a long-term cardiovascular outcomes study might be needed to gain approval

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