Cara Therapeutics Reports Results of Part A of KOURAGE-1 Study on Oral Difelikefalin in Notalgia Paresthetica

Cara Therapeutics, Inc. (Nasdaq: CARA), a biopharmaceutical company based in Stamford, Conn., has announced the results of their KOURAGE-1 study's Part A, which was aimed at evaluating the efficacy and safety of oral difelikefalin for moderate-to-severe pruritus in adult patients with notalgia paresthetica (NP). Unfortunately, oral difelikefalin did not show a significant clinical benefit at any dosage level when compared to a placebo. As a consequence, the company has decided to discontinue its clinical program for NP.

Christopher Posner, the President and Chief Executive Officer of Cara Therapeutics, expressed disappointment in the outcome, citing the strong proof-of-concept results and the substantial unmet need in treating this sensory neuropathy. Despite the setback, he extended gratitude to the patients and investigators who participated in the study. Moving forward, Cara Therapeutics will be winding down its Phase 2/3 clinical program in NP and will explore strategic alternatives to maximize shareholder value.

The KOURAGE-1 Part A study was a multicenter, randomized, double-blind, placebo-controlled trial. It was designed to establish the appropriate dose and sample size for the pivotal phases of the Phase 2/3 clinical program. In this study, 214 patients were randomly assigned to one of four groups: oral difelikefalin 2 mg twice a day (BID), 1 mg BID, 0.25 mg BID, or a placebo BID for a duration of 8 weeks. The primary evaluation criterion was the proportion of patients achieving a ≥4-point improvement from baseline in the weekly mean of the daily 24-hour Itch-Numeric Rating Scale (I-NRS) score by Week 8.

The outcome revealed that oral difelikefalin did not deliver a meaningful clinical benefit at any dose level compared to the placebo. However, the drug was generally well tolerated, consistent with safety profiles observed in prior trials.

As of March 31, 2024, Cara Therapeutics reported having approximately $70 million in cash, cash equivalents, and marketable securities.

Cara Therapeutics is a development-stage biopharmaceutical company focused on creating new treatment paradigms to improve the lives of patients suffering from pruritus. The company has developed an intravenous (IV) formulation of difelikefalin, which has received approval in the United States, European Union, and several other countries. This IV formulation is used to treat moderate-to-severe pruritus associated with advanced chronic kidney disease in adults undergoing hemodialysis and is out-licensed globally.