Biotech Values

[Whalatane]

CARA. great news for dialysis patients .re Pruritus ( itching ) \

Cara Therapeutics and Vifor Fresenius Medical Care Renal Pharma Announce Positive Results From Global KALM-2 Pivotal Phase 3 Trial of KORSUVATM Injection in Hemodialysis Patients with Pruritus
Statistically significant improvement in primary endpoint of proportion of patients with three point or greater reduction in mean Worst Itching Intensity NRS score vs. placebo (p=0.02) -

Statistically significant improvement in key secondary endpoint of proportion of patients with four point or greater reduction in mean worst itching intensity NRS score vs. placebo (p=0.01) -

KORSUVA Injection NDA and MAA submission expected in the second half of 2020 -

Cara to host conference call today at 8:30 a.m. ET -

Still a high placebo rate tho

KALM-2 Efficacy Data:
Primary Endpoint: The proportion of patients on 0.5 mcg/kg of KORSUVA Injection achieving a three-point or greater improvement from baseline in the weekly mean of the daily 24 hour Worst Itching Intensity Numeric Rating Scale (WI-NRS) score at week 12 was 54% vs.42% for patients on placebo (p= 0.02)
Key Secondary Endpoint: The proportion of patients on 0.5 mcg/kg of KORSUVA Injection achieving a four-point or greater improvement from baseline in the weekly mean of the daily 24 hour WI-NRS score at week 12 was 41% vs. 28% for patients on placebo (p= 0.01)
Itch-related Quality of Life Measures: Patients on KORSUVA Injection experienced a 12% and 29% numerical improvement in the average total Skindex-10 and total 5-D Itch scores respectively which didn’t meet statistical significance.

Kiwi