Phase 2 Topline Data
Amp Volatility Score
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)
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
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).
Updated by HC
CARA, Oral Korsuva, CR845, difelikefalin, Chronic Liver Disease, CLD, Topline data
Prior Data (click to view full image)
Trial Design / Revenue (click to view full image)
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