Cara Therapeutics Announces Positive Results From KALM-1 Pivotal Phase 3 Trial of KORSUVA™ Injection in Hemodialysis Patients with Pruritus

- Statistically significant improvement in primary endpoint of proportion of patients with three point or greater reduction in mean worst itching intensity NRS score vs. placebo (p=0.000019) –

- Statistically significant improvement in key secondary endpoint of proportion of patients with four point or greater reduction in mean worst itching intensity NRS score vs. placebo (p=0.000032) –

- KORSUVA Injection well-tolerated through 12 weeks of treatment -

- Company to host conference call today at 8:30 a.m. ET -

STAMFORD, Conn., May 29, 2019 (GLOBE NEWSWIRE) -- Cara Therapeutics, Inc. (CARA), a biopharmaceutical company focused on developing and commercializing new chemical entities with a primary focus on the treatment of pruritus by selectively targeting peripheral kappa opioid receptors, today announced positive topline data from the KALM-1 pivotal Phase 3 trial of KORSUVAâ„¢ (CR845/difelikefalin) Injection in hemodialysis patients with moderate-to-severe chronic kidney disease-associated pruritus (CKD-aP).

“We are extremely pleased with the robust topline results from our first pivotal Phase 3 trial of KORSUVA Injection and are particularly encouraged by the early anti-pruritic response with KORSUVA Injection, which resulted in statistically significant separation from placebo after only one week of treatment and a sustained significant benefit through 12 weeks,” said Derek Chalmers, Ph.D., D.Sc., President and Chief Executive Officer of Cara Therapeutics. “We look forward to reporting topline data from our second global Phase 3 trial, KALM-2, in the second half of this year and, assuming positive results, moving towards an NDA submission as quickly as possible thereafter.”

CKD-aP is an intractable systemic itch condition that occurs with high frequency and intensity in patients undergoing hemodialysis and peritoneal dialysis. Multiple studies estimate that at least 40 percent of patients with end-stage renal disease suffer from pruritus. The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to KORSUVA Injection for this indication.

“Itching is a significant problem for many of our hemodialysis patients and there is an unmet need for an effective treatment. I am impressed by the clinically meaningful efficacy demonstrated in this study,” said Steven Fishbane, M.D., Chief, Division of Kidney Disease and Hypertension, Northwell Health, Professor of Medicine at Hofstra/Northwell and a KALM-1 clinical investigator. “Relative to the favorable safety data, these results suggest that, if approved, this can be an important drug that could help many of our patients.”

KALM-1 Efficacy Data:

• Primary Endpoint: The proportion of patients on 0.5 mcg/kg of KORSUVA Injection achieving a  three-point or greater improvement from baseline in the weekly mean of the daily 24 hour Worst Itching Intensity Numeric Rating Scale (WI-NRS) score at week 12 was 51% vs. 28% for patients on placebo (p= 0.000019)
   
• Secondary Endpoints:
   
  • The proportion of patients on 0.5 mcg/kg of KORSUVA Injection achieving a four-point or greater improvement from baseline in the weekly mean of the daily 24 hour WI-NRS score at week 12 was 39% vs. 18% for patients on placebo (p= 0.000032)
    

• Itch-Related Quality of Life Measures: The impact of KORSUVA Injection on itch-related quality of life measures associated with CKD-aP was measured using validated self-assessment Skindex-10 and 5-D itch scales:
  • Patients on KORSUVA Injection experienced a 43% improvement in the average total Skindex-10 score at week 12 vs. patients on placebo (p= 0.0004)
  • Patients on KORSUVA Injection experienced a 35% improvement in the average total 5-D Itch score at week 12 vs. patients on placebo (p= 0.0009)

KALM-1 Safety and Tolerability:

KORSUVA was generally well-tolerated with a safety profile consistent with that seen in earlier KORSUVA clinical trials. Overall, the incidence of adverse events (AEs) and serious AEs were similar across both KORSUVA and placebo groups. The most common treatment emergent AEs reported in >5% of patients were diarrhea (9.5% KORSUVA vs 3.7% placebo), dizziness (6.9% KORSUVA vs 1.1% placebo), nasopharyngitis (KORSUVA 5.3% vs 3.2% placebo) and vomiting (5.3% KORSUVA vs 3.2% placebo).

Conference Call

Cara management will host a conference call today at 8:30 a.m. ET to discuss the results of the study.

To participate in the conference call, please dial (855) 445-2816 (domestic) or (484) 756-4300 (international) and refer to conference ID 2987032. A live webcast of the call can be accessed under "Events & Presentations" in the News & Investors section of the Company's website at www.CaraTherapeutics.com.

An archived webcast recording will be available on the Cara website beginning approximately two hours after the call.

KALM-1 Phase 3 Trial Design

The Phase 3 U.S. study is a multicenter, randomized, double-blind, placebo-controlled 12-week treatment trial with a 52-week open label extension phase that is designed to evaluate the safety and efficacy of 0.5 mcg/kg KORSUVA (CR845/difelikefalin) Injection in 350 hemodialysis patients with moderate-to-severe pruritus.

The primary efficacy endpoint is the proportion of patients achieving at least a three‑point improvement from baseline in the weekly mean of the daily 24‑hour WI-NRS score at week 12.

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