Stage (next event)
Phase 2 Topline Data
Catalyst Info & Data Links
TITLE: Oral Korsuva Pruritus CLD - Topline Data
ClinicalTrial.gov (NCT03995212): Study to Evaluate the Safety and Efficacy of Oral CR845 (Difelikefalin) in Patients With Primary Biliary Cholangitis (PBC) and Moderate-to-Severe Pruritus
WHAT IS THE CATALYST EVENT?
WHEN WILL THE EVENT (OR DID THE EVENT) OCCUR?
08-10-2020 Top-line data in the first half of 2021(Q2 2020 Financial Results)
05-2020: Corporate Presentation (slide 29)
Mechanism of Action
MECHANISM OF ACTION / RATIONALE
Difelikefalin (CR845) is a peripherally restricted, selective kappa opioid receptor agonist that exerts antipruritic effects by means of activation of kappa opioid receptors on peripheral neurons and immune cells. The hydrophilic small-peptide structure restricts passive diffusion across membranes, thereby limiting access to kappa opioid receptors in the central nervous system (Fishbane et al., 2020).
OCALIVA® (obeticholic acid) - Intercept Pharmaceuticals, Inc.
~7 million patients were diagnosed with CLD in 2013 in the US
~2.5 million patients received a prescription for an anti-pruritic
Updated by MV
Prior Data (click to view full image)
Trial Design / Revenue (click to view full image)
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