Study: Difelikefalin injection reduces itch intensity for patients on hemodialysis with pruritus
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Patients on hemodialysis with pruritus who received a difelikefalin injection experienced reduced itch intensity, according to phase 3 trial results from the KALM-2 study.
“We are very pleased with the positive topline data from our global, pivotal phase 3 trial of Korsuva injection, which reinforce the robust results we reported from our U.S. KALM-1 phase 3 trial last year,” Derek Chalmers, PhD, DSc, president and CEO of Cara Therapeutics, said in a press release issued by the company.
Healio Nephrology has previously reported on the benefits of the oral form of difelikefalin for patients with nondialysis-dependent CKD, as well as on reduced itch intensity with an IV bolus of the drug administered thrice-weekly for those on hemodialysis.
For phase 3 of the KALM-2 study, 473 patients on hemodialysis, who also had moderate to severe pruritus, were randomized to receive a 0.5 mcg/kg injection of difelikefalin or placebo. The primary endpoint of the study was the proportion of patients who achieved at least a three-point improvement in the weekly mean of the daily 24-hour worst itching intensity numeric rating scale (WI-NRS) score at week 12.
Researchers found 54% of patients who received the injection met this primary endpoint compared with 42% who received placebo.
Furthermore, results showed 41% of patients who received the injection achieved a four-point or greater improvement from baseline in the weekly mean of the daily 24-hour WI-NRS score at week 12 vs. 28% of those who received placebo.
Regarding itch-related quality of life, patients on the injection experienced a 12% and 29% numerical improvement in the average total skindex-10 and total 5-D Itch scores, respectively, but the researchers noted these scores did not meet statistical significance.
After examining the safety profile of the drug, the incidence of adverse events was determined to be similar for both groups with the most common events (reported in more than 5% of patients) being diarrhea (8.1% for those with injection vs. 5.5% on placebo), falling (6.8% vs. 5.1%), vomiting (6.4% vs. 5.9%), nausea (6.4% vs. 4.2%) and dizziness (5.5% vs. 5.1%).
“I continue to be very impressed by the robust efficacy of Korsuva for the treatment of pruritus in our patients undergoing hemodialysis,” Steven Fishbane, MD, of Northwell Health and Hofstra/Northwell, said in the release. “Itching is a real issue for our hemodialysis patients and there are no approved treatments in the U.S. or Europe so I am encouraged by the potential of this drug to address a significant unmet need for our patients.”
As for the next steps, Chalmers said the company intends to submit a new drug application to the FDA in the second half of 2020.
“[W]orking with our partner Vifor Fresenius Medical Care Renal Pharma,” he added, “[we] plan to submit for Marketing Authorization Approval (MAA) to the European Medicines Agency (EMA) shortly thereafter.”
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