Late-breaking oral presentation to highlight data from KALM-1 pivotal Phase 3 trial of KORSUVA™ Injection in hemodialysis patients with pruritus
STAMFORD, Conn., Nov. 01, 2019 (GLOBE NEWSWIRE) -- Cara Therapeutics, Inc. (Nasdaq:CARA), a biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pruritus by selectively targeting peripheral kappa opioid receptors, today announced a late-breaking oral presentation and two posters on KORSUVA™ (CR845/difelikefalin) Injection will be presented at Kidney Week 2019, the American Society of Nephrology’s Annual Meeting, to be held November 5-10, 2019, in Washington, DC.
The late-breaking oral presentation will include data from KALM-1, the pivotal Phase 3 clinical trial of KORSUVA Injection in hemodialysis patients with moderate-to-severe chronic kidney disease-associated pruritus (CKD-aP), and the posters will include data from the Phase 2 trial of KORSUVA Injection in the same patient population. KORSUVA Injection is Cara’s first-in-class drug candidate designed to target kappa opioid receptors in the body’s peripheral nervous system, as well as certain immune cells.
Details for the presentations are as follows:
Late-Breaking Oral Presentation:
Title: Efficacy and Safety of Difelikefalin in Patients Undergoing Hemodialysis With Pruritus: Results From a Phase 3 Randomized, Controlled Study (KALM-1)
Abstract Number: FR-OR134
Date / Time: Friday, November 8, 2:45 to 3 p.m. ET
Presenter: Steven Fishbane, MD, Department of Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Great Neck, NY
Title: Difelikefalin Improved Quality of Life (5-D Itch Scale-Domains) in Hemodialysis Patients With Pruritus in an 8-Week Phase 2 Randomized, Placebo-Controlled Study
Poster Number: TH-PO245
Date / Time: Thursday, November 7, 10 a.m. to 12 p.m.
Presenter: Robert Spencer, Cara Therapeutics
Title: Difelikefalin Significantly Reduced Sleep Disturbance in Hemodialysis Patients With Moderate-to-Severe Pruritus in an 8-Week Phase 2, Randomized, Placebo-Controlled Study
Poster Number: TH-PO247
Date / Time: Thursday, November 7, 10 a.m. to 12 p.m. ET
Presenter: Sarbani Bhaduri, MD, Cara Therapeutics
For more information about Kidney Week 2019, visit https://www.asn-online.org/education/kidneyweek/.
About Cara Therapeutics
Cara Therapeutics is a clinical-stage biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pruritus by selectively targeting peripheral kappa opioid receptors (KORs). Cara is developing a novel and proprietary class of product candidates, led by KORSUVA™ (CR845/difelikefalin), a first-in-class KOR agonist that targets the body's peripheral nervous system, as well as certain immune cells. In both Phase 3 and Phase 2 trials, KORSUVA Injection has demonstrated statistically significant reductions in itch intensity and concomitant improvement in quality of life measures in hemodialysis patients with moderate-to-severe chronic kidney disease-associated pruritus (CKD-aP). KORSUVA Injection is currently being investigated in pivotal Phase 3 trials in hemodialysis patients with CKD-aP. Oral KORSUVA is in Phase 2 trials for the treatment of pruritus in patients with CKD, atopic dermatitis and primary biliary cholangitis (PBC).
The FDA has conditionally accepted KORSUVA™ as the trade name for difelikefalin injection. CR845/difelikefalin is an investigational drug product and its safety and efficacy have not been fully evaluated by any regulatory authority.
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Source: Cara Therapeutics, Inc.