GNFT

Elafibranor

Primary Biliary Cholangitis

Stage (next event)

Expected Date

Phase 3 (Data)

TBD

Catalyst Info & Data Links

TITLE: Elafibranor in Primary Biliary Cholangitis 

  • Phase 3 - ClinicalTrial.gov (NCT04526665): Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) (ELATIVE)

  • Phase 2 - ClinicalTrial.gov (NCT03124108): Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) and Inadequate Response to Ursodeoxycholic Acid


WHAT IS THE NEXT CATALYST EVENT?

  • Phase 3 Data


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

  • 2023


PRIOR DATA/EVENTS

PRESS RELEASES

MECHANISM OF ACTION

  • Targeting PPAR receptors has shown multiple beneficial activities, including the reduction of bile acid synthesis, improved detoxification of bile in the bile duct and anti-inflammatory activity. In third-party clinical trials, drugs targeting PPAR receptors resulted in a significant decrease in ALP and improved biochemical profiles and pruritus in PBC patients.

  • Patients with PBC often have elevated ALP, and studies have shown a correlation between elevated ALP levels and increased risk of adverse patient outcomes. We have observed elafibranor’s effect in lowering ALP levels in our clinical trials, including our Phase 2 clinical trial in PBC.

  • In addition, targeting PPARα is proven to have the potential to alleviate pruritus (itching)1, the major symptom of the disease, which is still not addressed by any of the therapies currently available.

Updated by MV

Prior Data (click to view full image)

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Trial Design / Revenue (click to view full image)

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