Cara Therapeutics Presents Late-Breaking Results of KARE Phase 2 Trial of Oral Difelikefalin (Oral KORSUVA™) in Atopic Dermatitis Patients with Moderate-to-Severe Pruritus at the 2021 European Academy of Dermatology and Venereology (EADV) Virtual Congress
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
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Examples of these forward-looking statements include statements concerning the future development of Oral KORSUVA for pruritus in patients with mild-to-moderate atopic dermatitis and the potential for Oral KORSUVA to treat these patients. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Risks are described more fully in Cara Therapeutics’s filings with the Securities and Exchange Commission, including the "Risk Factors" section of Cara Therapeutic’s Annual Report on Form 10-K for the year ended December 31, 2020 and its other documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law,
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Source: Cara Therapeutics, Inc.