Results from global KALM-2 pivotal Phase 3 trial of KORSUVA™ Injection in hemodialysis patients with pruritus to be presented
NDA submission for KORSUVA Injection on track for fourth quarter 2020
#CARA "announced that results from its KALM-2 pivotal Phase 3 trial of KORSUVA™ (CR845/difelikefalin) Injection in hemodialysis patients with moderate-to-severe chronic kidney disease-associated pruritus (CKD-aP) will be presented at the American Society of Nephrology (ASN) Kidney Week 2020 annual meeting, which is being held virtually from October 22-25, 2020.
Details for the oral presentation are as follows:
Title: Efficacy and Safety of Difelikefalin for Moderate-to-Severe CKD-Associated Pruritus: A Global Phase 3 Study in Hemodialysis Patients (KALM-2) Abstract Number: FR-OR24 Date and Time: Friday, October 23, 5 to 7 p.m. ET Presenter: Thomas D. Wooldridge, M.D., Nephrology and Hypertension Associates, Ltd., Tupelo, MS
In April 2020, the Company announced positive top-line results from KALM-2. The trial met the primary endpoint, with a statistically significant proportion of patients on KORSUVA Injection achieving a three-point or greater improvement from baseline in the weekly mean Worst Itching Intensity Numeric Rating Scale (NRS) versus placebo (p=0.02) at week 12. The trial also met the key secondary endpoint, with a statistically significant proportion of patients on KORSUVA Injection achieving a four-point or greater improvement from baseline in the weekly mean Worst Itching Intensity NRS versus placebo (p=0.01) at week 12. KORSUVA Injection was generally well-tolerated through 12 weeks of treatment with a safety profile consistent with prior clinical trials.
The Company remains on track to submit a New Drug Application for KORSUVA Injection to the U.S. Food and Drug Administration in the fourth quarter of 2020" (see press release HERE).