Cara Therapeutics announced positive topline data from the KALM-1 pivotal phase 3 trial of Korsuva (CR845/difelikefalin injection), a kappa opioid receptor agonist, in hemodialysis patients with moderate to severe chronic kidney disease-associated pruritus (CKD-aP).
The KALM-1 trial was a multicenter, double-blind, placebo-controlled 12-week study with a 52-week open label extension phase that evaluated the safety and efficacy of Korsuva injection in 350 hemodialysis patients with moderate to severe CKD-aP. Patients were randomized to receive either intravenous Korsuva 0.5mcg/kg or placebo 3 times a week for 12 weeks.
Results showed a statistically significant improvement in the proportion of patients achieving a 3-point or greater improvement from baseline in the weekly mean of the daily 24‑hour Worst Itching Intensity Numerical Rating Scale (WI-NRS) score at week 12 (primary endpoint) compared with placebo (51% vs 28%; P =.000019). In addition, treatment with Korsuva showed a statistically significant improvement in the proportion of patients achieving at least a 4-point improvement from baseline in the weekly mean of the daily 24-hour WI-NRS score (secondary endpoint) compared with placebo (39% vs 18%; P =.000032).
“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 1 week of treatment and a sustained significant benefit through 12 weeks,” said Derek Chalmers, PhD, DS, 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.”
Regarding safety, Korsuva was generally well-tolerated. The most common adverse reactions were diarrhea, dizziness, nasopharyngitis and vomiting.
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