“Based on its mechanism of action mediated by kappa receptors on peripheral sensory neurons and certain immune cells within the skin, we believe that KORSUVA™ has the potential to be an important symptomatic treatment for pruritus across a range of clinical conditions and we are pleased to begin dosing in the CLD population,” said
Phase 1 Trial Design
The Phase 1 trial is an open-label study designed to evaluate the safety and PK profile of repeated doses of oral KORSUVA™ (twice daily) in up to 60 patients with chronic liver disease (CLD) and up to 12 matched healthy control subjects. KORSUVA™ (1.0 mg tablet strength) will be evaluated over an eight-day treatment period in patients with mild, moderate or severe CLD based on their Child-Pugh classification (i.e, Class A, B and C). In addition, PK and safety tolerability will be assessed with KORSUVA™ up to 5.0 mg tablet strength in mild and moderate CLD patients.
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.
About Chronic Liver Disease-Associated Pruritus (CLD-aP)
CLD-aP is an intense, intractable, debilitating condition that disrupts daily activities and sleep in patients with CLD, and consequently significantly impairs their quality of life. It leads to significant scratching and, in severe cases, results in excoriations and prurigo nodularis. Although the pathophysiology is not well understood, it is likely multi-factorial, involving immune system dysregulation (including elevated pro-inflammatory activity) and imbalance in the endogenous opioid system.1 Based on annual prescriptions written for the symptomatic treatment of CLD-aP across liver conditions, it is estimated that approximately 2.5 million patients in
- Bergasa, N.: Medical Hypotheses; 86-89, 2018
- IMS Pruritus Market Landscape Analysis,
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Examples of these forward-looking statements include statements concerning the potential of Oral Korsuva (CR845/difelikefalin) as a treatment for moderate-to-severe pruritus in CLD patients and statements concerning the initiation of the Company's planned Phase 2 trial of Oral Korsuva for the treatment of CLD patients suffering from moderate-to-severe associated pruritus. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Risks are described more fully in
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Source: Cara Therapeutics, Inc.