Intercept rollercoaster continues with NASH, PBC updates
This article was originally published in Scrip
Intercept Pharmaceuticals fell 30.1% to $172.59 per share on 7 November after data from the Phase II FLINT clinical trial for obeticholic acid (OCA) were published in The Lancet, but the update provided little new information about the drug's safety and efficacy in non-alcoholic steatohepatitis (NASH).
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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.
With Gilead snapping at its heels in NASH, Intercept will be pleased with its product's positive reimbursement recommendation in the UK for rare disease PBC; physicians will have the opportunity to familiarize themselves with Intercept's offering.
Lack of pruritus and a positive cardiometabolic profile could give elafibranor an advantage as it competes with Intercept’s Ocaliva to be the first drug therapy to market in NASH. The French biotech also is working on a biomarker algorithm to optimize patient selection.