Cara Therapeutics(US:CARA)2019-06-07 14:55KORSUVA™ Development Programs - KORSUVA™ Injection is in Phase 3 development for CKD-associated pruritus (CKD-aP) in hemodialysis patients, with positive topline data from the KALM-1 trial reported in May 2019 and topline data from the KALM-2 trial expected in 2H19[3] - Oral KORSUVA™ has multiple programs including a Phase 2 trial ongoing for CKD-aP in non-dialysis patients with data expected in 2H19, a Phase 2 trial expected to initiate in 2Q19 for chronic liver disease-associated pruritus, and a Phase 2 trial expected to initiate around mid-year 2019 for atopic dermatitis[3] - The FDA has conditionally accepted KORSUVA™ as the trade name for CR845 / difelikefalin for pruritic indications[8] Market Opportunity - Chronic kidney disease-associated pruritus (CKD-aP) affects approximately 40% to 50% of patients with renal failure[5] - Approximately 20% to 30% of patients with cholestatic liver disease experience pruritus[5] - In the U S, approximately 50% of the 20 million atopic dermatitis (AD) patients seek treatment for pruritus[6] - In the U S, approximately 50% of the 8 million psoriasis patients seek treatment for pruritus[7] - Approximately 60% to 70% of hemodialysis (HD) patients report pruritus[10] - Approximately 30% to 40% of hemodialysis patients with CKD-aP have moderate to severe itch intensity[10] - There are approximately 468,000 patients on dialysis in the US[11] KALM-1 Trial Results - In the KALM-1 Phase 3 trial, 51% of KORSUVA™-treated subjects achieved ≥3 point improvement in weekly mean of daily worst itching intensity NRS (WI-NRS) compared to 28% in the placebo group (p = 000019)[21] - In the KALM-1 Phase 3 trial, 39% of KORSUVA™-treated subjects achieved ≥4 point improvement in weekly mean of daily WI-NRS compared to 18% in the placebo group (p = 000032)[22] Financial Status - As of March 31, 2019, the company had $1561 million in cash and marketable securities[38]