Cara Therapeutics Announces Topline Results From KARE Phase 2 Dose-Ranging Trial of Oral KORSUVA in Atopic Dermatitis Patients with Moderate-to-Severe Pruritus - Seite 2

Primary Efficacy Endpoint

• KARE’s primary efficacy endpoint was change from baseline in the weekly mean of the daily 24-hour Itch NRS score at week 12 of the treatment period. Although no dose group met this endpoint, a statistically significant improvement from baseline was evident as early as week 1 for the 1 mg dose group which was sustained through 75% of the treatment period.
• In a prespecified analysis, a statistically significant change in the primary efficacy endpoint was observed in the mild-to-moderate (BSA<10%) patient population (p=0.036, All doses vs placebo) which was evident at week 1 and sustained through the treatment period.

Key Secondary Endpoint

• The key secondary endpoint for KARE was the assessment of the proportion of patients achieving an improvement from baseline of ≥4 points with respect to the weekly mean of the daily 24-hour Itch NRS score at week 12 (4-point Responder Analysis). No dose group met this endpoint for the ITT population.
• Prespecified analysis by disease severity indicated a statistically significant improvement in the 4-point Responder Analysis in the mild-to-moderate (BSA<10%) patient population with 32% of KORSUVA-treated patients achieving a ≥4 point reduction in NRS at Week 12 versus 19% in the placebo group (p=0.033, All doses vs placebo). A statistically significant improvement was also achieved for the 0.5 mg dose (p=0.046, 0.5mg vs placebo).

Oral KORSUVA was generally well-tolerated across all doses. Overall, the incidence of treatment-emergent adverse events (AEs) was generally similar across KORSUVA and placebo groups. The most common treatment-emergent AEs reported in >5% of patients in any KORSUVA group and greater than placebo were abdominal pain, nausea dry mouth, headache, dizziness and hypertension (5/77 patients in 1 mg dose group; 4/5 of patients had documented prior history of hypertension at enrollment).

About Atopic Dermatitis

AD is a chronic, pruritic inflammatory dermatosis that affects up to 25% of children and 2-5% of adults (Eichenfeld et al 2015, Barbarot 2018). Pruritus is an integral part of AD and can aggravate the disease due to scratching. Itch is so common in AD that AD is often described as the itch that rashes (Boguniewicz M (2005). Pruritus prevalence in AD patients is greater than 80% and greatly impairs the quality of life of AD patients by causing sleep and psychological disturbance. (Mochizuki H, Schut 2005; Farmer WS, 2017) Both quality of life and psychosocial well-being are known to negatively correlate with itch severity.(Yosipovitch G, 2008)