Cara to wind down clinical program in NP and explore strategic alternatives

Cara Therapeutics announced the outcome from the dose-finding Part A of the KOURAGE-1 study evaluating the efficacy and safety of oral difelikefalin for moderate-to-severe pruritus in adult patients with notalgia paresthetica, NP . Oral difelikefalin did not demonstrate a meaningful clinical benefit at any dose compared to placebo, resulting in the Company’s decision to discontinue the clinical program in NP.”Given our strong proof-of-concept results in NP and the significant unmet need in this sensory neuropathy, we are disappointed that oral difelikefalin did not demonstrate a meaningful improvement in pruritus compared to placebo in the KOURAGE-1 Part A study,” said Christopher Posner, President and Chief Executive Officer of Cara Therapeutics. “We are grateful for the patients and investigators who participated in this study. We will be winding down the Phase 2/3 clinical program in NP and exploring strategic alternatives focused on maximizing shareholder value.” KOURAGE-1 Part A was a multicenter, randomized, double-blind, placebo-controlled study designed to inform the dose and sample size for the pivotal portions of the Phase 2/3 clinical program. Oral difelikefalin did not demonstrate a meaningful clinical benefit at any dose compared to placebo. The drug was generally well tolerated with a safety profile similar to prior trials. As of March 31 the Company had approximately $70M in cash, cash equivalents, and marketable securities.