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1st December 2021
Topical asivatrep, a transient receptor potential vanilloid subfamily V member 1 (TRPV1) antagonist, has been shown to be more effective than placebo in patients with mild to moderate atopic eczema. This was the finding from a Phase III trial by researchers from the Department of Dermatology, Hallym University, South Korea.
TRPVI is a non-selective cation channel which is expressed by keratinocytes, mast cells and sensory neurons related to itch, especially itch related to the release of histamine. Moreover, in vitro study data suggests that antagonism of TRPVI can suppress the atopic eczema-like symptoms by accelerating recovery of the skin’s barrier. More specifically, in animal models of atopic eczema-like dermatitis, topical asivatrep, has demonstrated improvements in eczema symptoms and the barrier function of the skin. In a dose ranging clinical study in adults with atopic eczema, topical asivatrep 1% was found to provide the greatest improvement in disease severity.
For the present study, the Korean team used a 1% formulation of asivatrep based on the results of the dose ranging study, for a Phase III, randomised, double-blind, placebo-controlled trial. Included patients were aged 12 years and older, with mild to moderate atopic eczema, defined by an investigators’ global assessment (IGA) score of 2 (mild) or 3 (moderate), and which affected between 5 and 30% of their body. The primary efficacy endpoint of the trial was the proportion of patients with an IGA score of 0 or 1 (i.e., clear or almost clear) after 8 weeks of treatment. Secondary endpoints included changes in EASI score, a pruritus visual analogue scale (VAS) score and a sleep disturbance score at several time points, including week 8.
A total of 240 patients with a mean age of 25.6 years (45.6% female) were included in the analysis with 157 assigned to topical asivatrep. Most (58.3%) had moderate severity atopic eczema. However, due to withdrawals and patient violations, the final analysis was based on a sample of 231 patients (153 asivatrep).
After 8 weeks of treatment, the proportion of patients achieving an IGA score of 0/1 was 36% in the asivatrep group and 12.8% in the placebo arm (p < 0.001). With respect to EASI scores, the greatest difference was observed at week 8 (44.3% vs 21.4%, asivatrep vs placebo, p < 0.001), with 9.8% of those receiving asivatrep achieving an EASI90 (i.e., 90% reduction in EASI score) compared to only 2.6% in the placebo group (p = 0.046).
There were also significant reductions in pruritus VAS scores and measures of sleep disturbance with asivatrep. In terms of safety, topical asivatrep was well tolerated and while the incidence of treatment-emergent adverse effects was slightly higher with asivatrep compared to placebo, the difference was non-significant.
The authors concluded that treatment with asivatrep cream, as a first-in-class topical agent, may be a novel treatment for patients with atopic eczema.
Park CW et al. Asivatrep, a TRPV1 antagonist, for the topical treatment of atopic dermatitis: Phase 3, randomized, vehicle-controlled study (CAPTAIN-AD). J. Allergy Clin Immunol 2021