Positive Results from Korsuva for Pruritis
Cara Therapeutics Postive Results from Korsuva Trial
On May 29, 2019 Cara Therapeutics (CARA) announced positive topline data from the KALM-1 pivotal Phase 3 trial of its Korsuva in hemodialysis patients with moderate-to-severe chronic kidney disease-associated pruritus (itching) (CKD-aP).
Chronic kidney disease-associated pruritus is an intractable frequent systemic intense itch that occurs in patients undergoing hemodialysis and peritoneal dialysis. Studies demonstrate that around 40% of patients with the end-stage renal disease suffer from pruritus. The FDA has granted Breakthrough Therapy designation to Korsuva Injection for this indication.
The recently announced KALM-1 trial’s results demonstrate that Korsuva met the trial’s primary and secondary endpoints. Patients taking Korsuva experienced a 43% improvement in the average total Skindex-10 score at week 12 vs. patients on placebo. Furthermore, patients on Korsuva experienced a 35% improvement in the average total 5-D Itch score at week 12 vs. patients on placebo.
Korsuva was generally well-tolerated. Adverse events (AEs) incidnece were similar across both Korsuva and placebo groups. The most common treatment-emergent AEs reported in >5% of patients were diarrhea (9.5% Korsuva vs 3.7% placebo), dizziness (6.9% Korsuva vs 1.1% placebo), nasopharyngitis (Korsuva 5.3% vs 3.2% placebo) and vomiting (5.3% Korsuva vs 3.2% placebo).
Derek Chalmers, Ph.D., D.Sc., President and Chief Executive Officer of Cara expects the reporting of topline data from the second global Phase 3 trial, KALM-2, in the second half of this year. In the case of positive results the firm would quickly move towards an NDA submission for approval.
On May 23, 2018 under our News & Comments section Prohost posted, “Cara Therapeutics has good news“. In the article we talk discuss the positive news about CARA’s Korsuva and CARA’s signing agreement with the renowned marketer Vifor Fresenius Medical Care Renal Pharma Ltd (VFMCRP) which specializes in chronic kidney diseases.
Here were our observations at the time:
The news is about CARA’s unique product Korsuva; demonstrating statistically significant reductions in itch intensity and concomitant improvement in the quality of life in hemodialysis patients with moderate-to-severe chronic kidney disease-associated pruritus (CKD-aP). CKD pruritis is debilitating and has yet to find a treatment. All this is good news but the best news is the announcement of CARA’s signing a marketing agreement with VFMCRP, the distinguished marketers specialized in kidney dialysis. The signing of this marketing agreement highlighted Cara as a firm with solid scientific fundamentals with a winner product.
The approval of Korsuva injection is great news for Cara and its shareholders. It could triple CARA’s market cap.
The difference between last year and today is that today CARA has more positive news from a late Phase 3 trial. This news is expected to increase the odds of Korsuva’s approvals over last year’s odds. Additionally, CARA is currently one step away from filing NDA for the approval of its anti-itching drug Korsuva.
We are looking forward to the final results and the filing for approval before the end of 2019.
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