$CARA Announces Positive Top-Line Data From Part A of Phase 2/3 Trial

Met primary endpoint with 68% reduction in worst itching scores versus placebo after eight-week treatment period (p<0.0019)

Met secondary endpoint in quality of life domains versus placebo after eight-week treatment period (p<0.0007)    

I.V. CR845 well tolerated after eight weeks of treatment    

Conference call today at 8:30 a.m. EDT to review results and next steps  

Cara Therapeutics, Inc. (CARA), a biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pain and pruritus by selectively targeting peripheral kappa opioid receptors, today announced positive top-line results from Part A of its Phase 2/3 trial showing that I.V. CR845 met both primary and secondary endpoints for efficacy (reduced itching and improved quality of life, respectively) in patients with uremic pruritus (UP) with statistical significance. UP is an intractable and debilitating systemic itch condition with a high prevalence in patients with chronic kidney disease (CKD), for which there are no approved therapies in the United States.

“We are extremely pleased with these results, where I.V. CR845 demonstrated sustained clinical and quality of life benefits in dialysis patients suffering from UP and supports the viability of this therapeutic approach for the long-term treatment of this unmet medical need,” said Derek Chalmers, Ph.D., D.Sc., President and Chief Executive Officer of Cara Therapeutics. “As a next step, we plan to meet with the FDA to finalize the trial design of Part B of this Phase 2/3 study and to initiate patient recruitment later this year.”

“These exciting results underscore I.V. CR845’s potential, if successfully developed, to become an approved therapy in the U.S. for CKD patients suffering from UP,” said Gil Yosipovitch, M.D., Professor of Dermatology, Miller School of Medicine, and Director of the Miami Itch Center at the University of Miami. “There is an unmet medical need for an effective long-term therapy for treating this intractable pruritus and providing meaningful improvement in the quality of life of these patients under dialysis treatment.”

“This study demonstrated encouraging, statistically significant improvements across quality of life measures for hemodialysis patients with this condition,” said Mark Unruh, M.D., Chair of the Department of Internal Medicine at the University of New Mexico School of Medicine. “Importantly, these improvements persisted for the entire eight-week treatment period, with the anti-itch effect apparently sustained over time, suggesting that CR845 has the potential to be an effective treatment for this difficult condition, if successfully developed and approved.”

I.V. CR845 Phase 2/3 UP Trial Design and Top-line Results

Part A of the Phase 2/3 UP trial was a randomized, double-blind, placebo-controlled trial of three doses of I.V. CR845 (0.5 ug/kg, 1.0 ug/kg, and 1.5 ug/kg) administered three times per week after dialysis over an eight-week treatment period in 174 patients with moderate-to-severe UP.

The primary endpoint was the change from baseline of the mean worst itching score for week eight (days 51-57) based on a validated 0-10 Numeric Rating Scale (NRS). Patients receiving I.V. CR845 experienced a 68 percent greater reduction from baseline in worst itch scores than those receiving placebo (p-value<0.0019).

The secondary endpoint focused on quality of life measures associated with pruritus using the Skindex-10 score, a validated self-assessment scale with higher scores indicating worse quality of life. Patients receiving I.V. CR845 experienced a 100 percent greater reduction from baseline in the average total Skindex-10 score at week eight than those receiving placebo (p-value<0.0007). The total average Skindex-10 score reflected statistically significant reductions in each of the three Skindex-10 domains; disease (p-value=0.0001), mood/emotional distress (p-value=0.01), and social functioning (p-value=0.009).

Overall, I.V. CR845 was well tolerated over the eight-week treatment period and the unblinded Drug Safety Monitoring Board did not report any significant drug-related events during the course of the trial. The most common adverse events were transient paresthesia (primarily mid-facial tingling or numbness) and dizziness, as reported in previous clinical studies of I.V. CR845.