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TITLE: Korsuva IV (CR845 IV) in Pruritus CKD-HD - NDA Submission
WHAT IS THE CATALYST EVENT?
WHEN WILL THE EVENT (OR DID THE EVENT) OCCUR?
H2 2020: NDA Submission
05-11-2020 First Quarter 2020 Financial Results
10-14-2019 Phase 3 KALM-II Interim Results PR (Cara Therapeutics Announces Completion of Interim Statistical Assessment and Small Increase in Target Enrollment for KALM-2 Phase 3 Global Trial of KORSUVA™ Injection in Hemodialysis Patients with Pruritus)
05-29-2019 Phase 3 KALM-I Results PR (Cara Therapeutics Announces Positive Results From KALM-1 Pivotal Phase 3 Trial of KORSUVA™ Injection in Hemodialysis Patients with Pruritus)
2017: (Kidney Week) Randomized, Placebo-Controlled Study on the Efficacy of CR845 inReducing Chronic Kidney Disease-associated Pruritus in Hemodialysis Patients
No date: Efficacy and Safety of Difelikefalin in Patients Undergoing Hemodialysis With Pruritus: Results From a Phase 3 Randomized, Controlled Study (KALM-1)
05-2020: Corporate Presentation (slide 6-15)
2020: A phase 3 trial of difelikefalin in hemodialysis patients with pruritus. New England Journal of Medicine, 382(3), 222-232.
>500K patients undergoing dialysis in the US
~60% of end-stage renal disease (ESRD) patients have pruritus
~40% have moderate to severe pruritus
Source - May 2020 Corporate Presentation (slide 7)
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, Korsuva IV (CR845 IV), Pruritus CKD-HD, NDA
Prior Data (click to view full image)
Trial Design / Revenue (click to view full image)
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