ICPT

Ocaliva

Adult nonalcoholic steatohepatitis (NASH)

Stage (next event)

Expected Date

NDA Resubmission

2021

Catalyst Info & Data Links

TITLE: Ocaliva in Adult nonalcoholic steatohepatitis (NASH) - NDA Resubmission

  • ClinicalTrial.gov NCT02548351: Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment (REGENERATE)


WHAT IS THE CATALYST EVENT?

  • NDA Resubmission


WHEN WILL THE EVENT (OR DID THE EVENT) OCCUR?


PRIOR DATA/EVENTS

PRESS RELEASE

Mechanism of Action

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. (page 10

COMPETITORS

  • Cenicriviroc by Allergan

  • Cotadutide by AstraZeneca

  • Elafibranor by Genfit

  • Resmetirom by Madrigal Pharmaceuticals

  • Selonsertib, firsocostat and cilofexor by Gilead

  • Tropifexor and licogliflozin by Novartis

MARKET

  • ~19 million NASH patients

  • ~16 million  patients with fibrosis due to NASH

  • ~1.5M under Hep/GI care

  • Source: J.P. Morgan 38th Annual Healthcare Conference (slide 13) 

Updated by HC

Prior Data (click to view full image)

Chart

Trial Design / Revenue (click to view full image)

Chart

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ICPT Ocaliva Phase 3 Readout

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