Cara Therapeutics shares data from part a of notalgia paresthetica trial
Betsy Goodfellow | June 13, 2024 | News story | Research and Development | Cara Therapeutics, Neurology, clinical trial, notalgia paresthetica, pruritus
Cara Therapeutics has announced the outcome from the dose-finding Part A of the KOURAGE-1 study which assessed the efficacy and safety of oral difelikefalin for moderate-to-severe pruritus in adult patients with notalgia paresthetica (NP).
The drug did not demonstrate a meaningful clinical benefit in any dose compared to placebo, therefore the company has decided to discontinue this clinical programme in NP.
The trial was part of a multicentre, randomised, double-blind, placebo-controlled study designed to inform the dose and sample size for the pivotal parts of the phase 2/3 clinical programme. According to the press release, ‘in Part A, 214 patients were randomised to one of four arms: oral difelikefalin 2mg twice a day (BID), 1mg BID, 0.25mg BID or placebo BID for eight weeks. The primary endpoint 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 at Week 8’.
The drug did not demonstrate a meaningful clinical benefit at any of these doses, however it was generally well tolerated and had a similar safety profile to previous trials.
Christopher Posner, president and chief executive officer of Cara Therapeutics, commented: “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. We are grateful for the patients and investigators who participated in this study. We will be winding down the phase 2/3 clinical programme in NP and exploring strategic alternatives focused on maximising shareholder value.”
Betsy Goodfellow
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