Cara Therapeutics Inc. (NASDAQ: CARA) has announced a Phase II KARE clinical study for oral difelikefalin in moderate to severe pruritus treatment of patients with mild to severe atopic dermatitis (AD).

The study enrolled 401 AD subjects  

Co-director of the Centre of the Study of Itch and Sensory Disorders at Washington University School of Medicine, Brian Kim, presented the study findings on October 2, 2021, during the Late Breaking News session of the virtual European Academy of Dermatology and Venereology Congress.

Throughout a 12-week treatment period, 401 patients with AD with moderate-to-severe pruritus were randomized to receive oral difelikefalin at doses of 0.25 mg, 0.5 mg, or 1.0 mg, or placebo. In a predetermined analysis, subjects with mild-to-moderate Alzheimer’s disease were included. BSA10 was found in around 64% of the individuals, and the results of this “Itch Dominant AD” subgroup were provided. A mouse model of Alzheimer’s disease was also employed to examine difelikefalin effects on the severity of lesion and itch.

KARE study didn’t meet the primary endpoint 

Despite the study failing to meet the primary endpoint with any dose group that received difelikefalin in the overall population, there was a considerable improvement (p=0.039) in itch after 12 weeks in the combined dose group for subjects with BSA of below 10%. Notably, in the itch-dominant AD  subpopulation, there was significant itch reduction with difelikefalin from two days. Additionally, a bigger number of the subjects in the combined difelikefalin cohort achieved a more than 4 point improvement in i-NRS after 12 weeks relative to placebo. Difelikefalin was well tolerated with mild to moderate adverse events.

Kim said, “Patients with mild-to-moderate AD commonly exhibit moderate-to-severe pruritus which is inadequately addressed by available topical medications. Together, the results of the KARE clinical study and the AD mouse model support the role of difelikefalin as a potential novel, systemic antipruritic agent that may effectively address pruritus in patients with itch-dominant AD.”

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