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CCARA THERAPEUTICS Cara Therapeutics Reports Third Quarter 2021 Financial Results November 8 , 2021 -KORSUVA ™ ( CR845 / difelikefalin ) injection Approved as First and Only Treatment for Chronic Kidney Disease - associated Pruritus ( CKD - aP ) in Adult Hemodialysis Patients byU.S. Food and Drug Administration ( FDA ) - - Christopher Posner Appointed President and Chief Executive Officer Effective November 9th , 2021 - - Conference call today at 4:30 p.m. ET STAMFORD , Conn . , Nov. 08 , 2021 ( 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 ( KORS ) , today announced financial results and operational highlights for the third quarter ended September 30 , 2021 . " I am excited to be joining Cara at a transformational point for the Company as it prepares for the commercial launch of KORSUVA injection for the treatment of moderate - to - severe pruritus associated with chronic kidney disease in hemodialysis patients in the first half of 2022 , " said Christopher Posner , Cara's newly appointed President and Chief Executive Officer . " As Cara continues to develop Oral KORSUVA across multiple patient populations , I believe the Company is well - positioned to become the leader in the treatment of itch - dominant medical conditions such as atopic dermatitis . " " In the third quarter of 2021 , Cara made significant progress across our development programs , culminating with the FDA approval of KORSUVA injection for moderate - to - severe pruritus associated with chronic kidney disease in hemodialysis patients , " said Derek Chalmers , Ph.D. , D.Sc. , President and Chief Executive Officer of Cara Therapeutics . " We are also making important clinical and regulatory progress with our Oral KORSUVA programs . Following recent guidance from the FDA , we aim to initiate Phase 3 programs with Oral Korsuva for the treatment of moderate to severe pruritus in both atopic dermatitis and non - dialysis dependent chronic kidney disease patients in the first quarter of 2022. Finally , I would like to welcome Chris as Cara's new President and CEO . Having worked closely with Chris as a Cara board member , I am confident in his ability to lead the Company through its next phase of development as an early commercial - stage biopharmaceutical company . " Third Quarter and Recent Developments : Leadership Appointments In November 2021 , the Company announced the appointment of Christopher Posner as President and Chief Executive Officer of Cara Therapeutics , effective November 9 , 2021. Mr. Posner joins the Company from LEO Pharma , Inc. , the US affiliate of LEO Pharma A / S , a global leader in medical dermatology , where he was President and Chief Executive Officer . Mr. Posner succeeds Dr. Derek Chalmers , who will transition to a Senior Advisor Role to the Company . KORSUVA Injection : Chronic Kidney Disease - Associated Pruritus ( CKD - aP ) : Hemodialysis In August 2021 , the FDA approved KORSUVA injection for the treatment of moderate - to - severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis , making it the first and only therapy currently approved by the FDA for treatment of this indication . The New Drug Application for KORSUVA injection received Priority Review by the FDA , granted to therapies that , if approved , would offer significant improvements in the safety or effectiveness of the treatment , diagnosis , or prevention of serious conditions when compared to standard applications , and was supported by positive data from two pivotal Phase 3 trials and supportive data from an additional 32 clinical studies . Following the FDA approval of KORSUVA injection , the Company has been collaborating with its commercial partner , Vifor Pharma , on the promotional launch of KORSUVA injection in the United States . In September 2021 , Vifor Pharma and Cara submitted the required documentation to the U.S. Centers for Medicare and Medicaid Services ( CMS ) to secure reimbursement for KORSUVA injection . Vifor Pharma expects to initiate the commercial launch of KORSUVA injection in the first half of 2022 , subject to CMS timelines . In October 2020 , Vifor Pharma and Cara agreed to an exclusive license to commercialize KORSUVA in the United States . That agreement features a Cara 60 % , Vifor Pharma 40 % profit - sharing arrangement in non - Fresenius Medical Care clinics in the U.S. Under the terms of this agreement , the Company received a $ 50.0 million common stock investment from Vifor in October 2021 at a 20 % premium to the 30 - day trailing average price of the Company's common stock for achievement of U.S. regulatory approval of KORSUVA injection . In addition , the Company is eligible to receive up to $ 240.0 million upon the achievement of certain sales - based milestones . Under another existing agreement , Vifor Fresenius Medical Care Renal Pharma Ltd. ( VFMCRP ) and the Company agreed to market KORSUVA injection to Fresenius Medical Care North America dialysis clinics in the U.S. under a Cara 50 % , Vifor Pharma 50 % profit - sharing arrangement . In October 2021 , the Company received a $ 15.0 million cash payment based on the achievement of U.S. regulatory approval of KORSUVA injection . In March 2021 , the Company and VFMCRP announced that the European Medicines Agency ( EMA ) accepted to review the Marketing Authorization Application ( MAA ) for difelikefalin injection for the treatment of pruritus associated with chronic kidney disease in hemodialysis patients . The EMA will review the application under the centralized marketing authorization procedure . If approved , difelikefalin would receive marketing authorization in all member states of the European Union ( EU ) , as well as in Iceland , Liechtenstein , and Norway . The EMA is expected to render a decision on the EU MAA in the second quarter of 2022 . Oral KORSUVA : Atopic Dermatitis ( AD ) In April 2021 , the Company announced top - line results from its Phase 2 KARE dose - ranging clinical trial of Oral KORSUVA for the treatment of moderate - to - severe pruritus in mild - to - severe atopic dermatitis patients . While the study did not meet its primary endpoint , in a pre - specified analysis of mild - to - moderate ( BSA < 10 % ) AD patients ( 64 % of ITT patient population ) , the study met its primary endpoint of WI - NRS change and secondary endpoint of 4 - point responder analysis in this patient population . Additionally , a statistically significant improvement was demonstrated in the 4 - point responder analysis , which we expect will be the Phase 3 registrational endpoint , in mild - to - moderate AD patients , with 32 % of KORSUVA - treated patients achieving a greater than 4 - point reduction vs. 19 % in placebo group ( p = 0.03 ) . Oral KORSUVA was generally well - tolerated across all doses . In the third quarter , the Company held an End - of - Phase 2 Meeting with the FDA to discuss the results from its Phase 2 KARE dose - ranging clinical trial of Oral KORSUVA for the treatment of moderate - to - severe pruritus in atopic dermatitis patients . Based on meeting guidance , the Company plans to initiate a Phase 3 program in AD patients in the first quarter of 2022 . Oral KORSUVA : Non - Dialysis Dependent ( NDD ) CKD - aP In April 2021 , the Company held an End - of - Phase 2 Meeting with the FDA to discuss the results of the Phase 2 trial of Oral KORSUVA in NDD CKD - aP and the potential Phase 3 program . Based on meeting guidance , the FDA indicated the acceptability of Stage 5 pre - dialysis CKD patients as a viable patient population for a Phase 3 trial . In November 2021 , the FDA provided written guidance indicating the patient population can be expanded to include the group of Stage 4 pre - dialysis patients with advanced CKD in a registration program consisting of two pivotal Phase 3 clinical trials . The Company expects to initiate this registration program in the first quarter of 2022 . Oral KORSUVA : Chronic Liver Disease - Associated Pruritus ( CLD - aP ) : Primary Biliary Cholangitis ( PBC ) The Company is currently conducting a Phase 2 trial of Oral KORSUVA for the treatment of pruritus in patients with hepatic impairment due to PBC . The trial is evaluating the safety and efficacy of Oral KORSUVA ( 1.0 mg tablet , twice daily ) versus placebo for 16 weeks . The Company continues to screen patients in this ongoing Phase 2 trial and , primarily due to the ongoing effects of the COVID - 19 pandemic on patient enrollment , currently expects to report top - line data in the first half of 2022 . Oral KORSUVA : Notalgia Paresthetica ( NP ) The Company initiated a Phase 2 trial of Oral KORSUVA for the treatment of moderate - to - severe pruritus in patients suffering from NP , a nerve disorder characterized by chronic pruritus of the upper back , in early 2021. The Phase 2 trial remains on track to be fully enrolled by year - end .