Stage (next event)
Catalyst Info & Data Links
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?
Q4 2020: NDA Submission
08-10-2020 Submit NDA for KORSUVA Injection in Q4 (Q2 2020 Financial Results).
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.
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).
>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)
Updated by MV
Prior Data (click to view full image)
Trial Design / Revenue (click to view full image)
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