Stage (next event)
Phase 3 (Data)
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?
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
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