Cara Therapeutics Reports First Quarter 2021 Financial Results

– U.S. Food and Drug Administration (FDA) Accepts New Drug Application (NDA) Filing and Grants Priority Review for KORSUVA™ Injection in CKD-aP –

– Conference call today at 4:30 p.m. ET –

STAMFORD, Conn., May 10, 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 first quarter ended March 31, 2021.

“During the first quarter of the year, we were very pleased with the FDA acceptance, with Priority Review, of our first NDA filing for our lead product candidate, KORSUVA™ Injection, for the treatment of moderate-to-severe pruritus in hemodialysis patients. With an expected Prescription Drug User Fee Act (PDUFA) target action date of August 23, 2021, we remain focused, along with our commercial partner, Vifor Pharma, on preparation for the U.S. launch of KORSUVA Injection in the second half of 2021, if approved,” said Derek Chalmers, Ph.D., D.Sc., President and Chief Executive Officer of Cara Therapeutics. “In addition, we continue to progress our Oral KORSUVA programs across a number of late-stage trials in patient populations where effective treatment of pruritus remains a significant unmet need. Having now generated Phase 2 data in pre-dialysis CKD patients and, more recently in mild-to-moderate atopic dermatitis patients in our KARE Phase 2 trial, we hope to initiate Phase 3 programs in both clinical indications by year-end.”

First Quarter and Recent Developments:

KORSUVA Injection: Chronic Kidney Disease-Associated Pruritus (CKD-aP): Hemodialysis

In February 2021, the FDA accepted the filing of the NDA for KORSUVA Injection for the treatment of moderate-to-severe pruritus in hemodialysis patients. Shortly after this decision, the FDA granted Priority Review for the NDA filing of KORSUVA Injection in March 2021 with an expected PDUFA target action date of August 23, 2021. Following these decisions, the potential approval and U.S. commercial launch of KORSUVA Injection could take place in the second half of 2021. If approved, KORSUVA Injection would be the first treatment for CKD-aP in hemodialysis patients.

In October 2020, the Company entered into a license agreement with Vifor (International) Ltd. (Vifor) under which it granted Vifor an exclusive license to commercialize KORSUVA Injection for the treatment of pruritus in hemodialysis patients in the United States under a Cara 60%, Vifor 40% profit-sharing arrangement. Under the terms of the agreement, upon U.S. regulatory approval of KORSUVA Injection, the Company will be eligible to receive a $50.0 million common stock investment at a 20% premium to the 30-day trailing average price of the Company’s common stock as of such date. In addition, the Company is eligible to receive payments of up to $240.0 million upon the achievement of certain sales-based milestones.

In March 2021, the Company and Vifor Fresenius Medical Care Renal Pharma Ltd. (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: 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. The FDA indicated the acceptability of Stage 5 pre-dialysis CKD patients as a viable patient population for a Phase 3 trial. The FDA also indicated the potential to use data from Cara’s previous trials of KORSUVA Injection in dialysis patients to support an approval based on a single Phase 3 clinical trial of Oral KORSUVA in the Stage 5 pre-dialysis population. The Company currently plans to initiate its Phase 3 program by year-end 2021. The Company also intends to continue discussions with the FDA on the potential inclusion of earlier stage CKD patients in the Phase 3 program.

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. The study did not meet its primary endpoint of Worst Itch – Numeric Rating Scale (WI-NRS) change from baseline at week 12 or secondary endpoint of 4-point responder analysis in the intent to treat (ITT) patient population. However, in a pre-specified analysis of mild-to-moderate (BSA