The following is a summary of “ATI-1777, a Topical Jak1/3 Inhibitor, May Benefit Atopic Dermatitis without Systemic Drug Exposure: Results from Preclinical Development and Phase 2a Randomized Control Study ATI-1777-AD-201,” published in the March 2024 issue of Dermatology by Changelian, et al.
Atopic dermatitis (AD), a chronic inflammatory skin condition, affects a significant portion of the population, particularly in developed countries. ATI-1777, a novel Jak1/3 inhibitor designed with localized action in the skin, shows promise in preclinical studies with limited systemic effects. Given the need for effective topical treatments for AD, evaluating the clinical efficacy of ATI-1777 is essential. For a study, researchers sought to assess the initial clinical efficacy of ATI-1777 topical solution in adults diagnosed with moderate or severe atopic dermatitis.
The study, 7-AD-201, was a study phase 2a, first-in-human, randomized, double-blind, vehicle-controlled trial. It aimed to investigate the efficacy, safety, tolerability, and pharmacokinetics of ATI-1777 topical solution over 4 weeks involving 48 participants with atopic dermatitis. The primary study’s primary endpoint was a reduction in the modified Eczema Area and Severity Index (EASI) score from baseline, serving as a measure of treatment efficacy.
Participants treated with ATI-1777 demonstrated a significantly greater reduction in the modified EASI score on day 28 compared to the vehicle-treated group. The percentage reduction from baseline was 74.45% in the ATI-1777 group, whereas it was 41.43% in the vehicle group (P < .001). Moreover, plasma concentrations of ATI-1777 remained below 5% of the half-maximal inhibitory concentration for Jak1/3 inhibition, indicating minimal systemic exposure. No serious adverse events or fatalities were reported during the study.
The topical application of ATI-1777 showed promising clinical efficacy in reducing the signs of atopic dermatitis without leading to significant systemic drug exposure. These findings suggest that ATI-1777 may offer a viable treatment option for patients with moderate to severe atopic dermatitis, warranting further investigation in larger clinical trials.
Reference: sciencedirect.com/science/article/pii/S2667026723000772
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