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Catalyst Info & Data Links
TITLE: Ocaliva in Primary Sclerosing Cholangitis
ClinicalTrial.gov (NCT02177136) Obeticholic Acid (OCA) in Primary Sclerosing Cholangitis (PSC) (AESOP)
WHAT IS THE NEXT CATALYST EVENT?
WHEN WILL THE EVENT (OR DID THE EVENT) OCCUR?
10-23-2017 POSITIVE RESULTS FROM PHASE 2 AESOP TRIAL EVALUATING OCA FOR THE TREATMENT OF PATIENTS WITH PRIMARY SCLEROSING CHOLANGITIS AT THE LIVER MEETING® 2017
20.9 cases of PSC per 100,000 in men
6.3 per 100,000 in women
Data from Olmsted County (USA) in the year 2000
MECHANISM OF ACTION / RATIONALE
Obeticholic acid is an agonist for FXR, a nuclear receptor expressed in the liver and intestine. FXR is a key regulator of bile acid, inflammatory, fibrotic, and metabolic pathways. FXR activation decreases the intracellular hepatocyte concentrations of bile acids by suppressing de novo synthesis from cholesterol as well as by increased transport of bile acids out of the hepatocytes. These mechanisms limit the overall size of the circulating bile acid pool while promoting choleresis, thus reducing hepatic exposure to bile acids.
Source - FDA Label (section 12.1)
Prior Data (click to view full image)
Trial Design / Revenue (click to view full image)
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