Benzinga | Oct 4, 2021 07:01AM EDT

Cara Therapeutics Presents Late-Breaking Results Of KARE Phase 2 Trial Of Oral Difelikefalin In Atopic Dermatitis Patients With Moderate-to-Severe Pruritus At The 2021 European Academy Of Dermatology And Venereology Virtual Congress

Cara Therapeutics, Inc. (NASDAQ:CARA), a biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pruritus by selectively targeting peripheral kappa opioid receptors, presented results from the KARE Phase 2 clinical trial of oral difelikefalin for the treatment of moderate-to-severe pruritus in mild-to-severe atopic dermatitis (AD) patients. Results were presented by Brian Kim, MD, Associate Professor of Dermatology and Co-Director of the Center for the Study of Itch and Sensory Disorders at Washington University School of Medicine, during the Late Breaking News session of the 2021 European Academy of Dermatology and Venereology (EADV) Virtual Congress on October 2, 2021.

The presentation summarized data from 401 subjects with AD and moderate-to-severe pruritus, who were randomized to receive oral difelikefalin at a dose of 0.25 mg, 0.5 mg or 1.0 mg, or placebo over a 12-week treatment period.

Subjects with mild-to-moderate AD were included in a prespecified analysis. Approximately 64% of subjects had BSA<10 and the results of this "Itch Dominant AD" subgroup were presented.

In addition, a mouse model of AD was used to test the effects of difelikefalin on itch and lesion severity.

Although the primary endpoint, change from baseline in Itch Numerical Rating Scale (I-NRS) score, was not met with any of the difelikefalin dose groups in the overall population, a significant improvement (p= 0.039) in itch was observed at week 12 in the combined difelikefalin dose group in subjects with BSA <10%. In this subpopulation of itch-dominant AD, significant reduction in itch with difelikefalin was evident as early as day 2. In addition, a significantly greater proportion of subjects (32% vs 19%; p<0.05) in the combined difelikefalin dose group versus placebo achieved a ?4-point improvement in I-NRS at week 12 (the required regulatory primary endpoint for Phase 3 pruritus programs). Difelikefalin was well-tolerated, with most adverse events (~95%) being mild or moderate in severity. The most commonly reported adverse events included abdominal pain, nausea, dry mouth, headache, dizziness, and hypertension. In the mouse model of AD, a rapid and significant anti-pruritic effect of difelikefalin was observed independently of effects on skin inflammation.

"Patients with mild-to-moderate AD commonly exhibit moderate-to-severe pruritus which is inadequately addressed by available topical medications," said Dr. Kim. "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."