Safety, pharmacokinetics, and efficacy of HY-072808 ointment, a novel PDE4 inhibitor, in adolescent and adult patients with mild-to-moderate AD.

IF 4.9 2区医学 Q1 PHARMACOLOGY & PHARMACY

Expert opinion on investigational drugs Pub Date : 2025-05-27 DOI:10.1080/13543784.2025.2510671

Feng Yao, Mingchao He, Jing Wang, Yao Li, Qian Zhang, Jingjing Yang, Jingying Wu, Qin Zhang, Renpeng Zhou, Meiling Zhang, Linying Meng, Liming Wu, Zhaoxing Chu, Wei Hu

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引用次数: 0

Abstract

Background: HY-072808 is a new PDE4 inhibitor with potential anti- atopic dermatitis (AD) effects. This study aimed to investigate its safety and pharmacokinetics in healthy individuals, and subsequently, its safety, pharmacokinetics, and efficacy in patients with mild-to-moderate AD.

Methods: We conducted double-blind, placebo-controlled, single and multiple ascending dose phase I clinical trials to assess the safety and pharmacokinetics of HY-072808 ointment in healthy subjects, followed by an open-label trial to evaluate its safety, pharmacokinetics, and efficacy in adolescent and adult patients with mild-to-moderate AD. The trials included 73 healthy subjects and 20 patients with AD.

Results: We found that HY-072808 had a favorable safety profile, with mild and manageable adverse events reported in both healthy subjects and AD patients. The pharmacokinetic analysis revealed that systemic exposure to HY-072808 remained minimal, with drug concentrations staying in the nanogram range. Furthermore, significant improvements in eczema severity, pruritus, and quality of life were observed in patients with mild-to-moderate AD, with 57.9% of patients achieving a ≥ 75% reduction in the EASI score.

Conclusion: These results indicate the potential of HY-072808 as an effective and well-tolerated treatment for mild-to-moderate AD, suggesting further clinical development for use in both adolescent and adult patients.

Trial registration: Chinese Clinical Trial Registry (No. ChiCTR2400087123).

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HY-072808软膏（一种新型PDE4抑制剂）在轻中度AD青少年和成人患者中的安全性、药代动力学和疗效

背景：HY-072808是一种新的PDE4抑制剂，具有潜在的抗特应性皮炎（AD）作用。本研究旨在研究其在健康人体内的安全性和药代动力学，进而研究其在轻中度AD患者体内的安全性、药代动力学和疗效。方法：我们通过双盲、安慰剂对照、单次和多次递增剂量的I期临床试验来评估HY-072808软膏在健康受试者中的安全性和药代动力学，随后进行一项开放标签试验来评估其在青少年和成人轻中度AD患者中的安全性、药代动力学和疗效。试验包括73名健康受试者和20名AD患者。结果：我们发现HY-072808具有良好的安全性，在健康受试者和AD患者中都报告了轻微和可控的不良事件。药代动力学分析显示，全身暴露于HY-072808仍然很小，药物浓度保持在纳克范围内。此外，在轻度至中度AD患者中观察到湿疹严重程度、瘙痒和生活质量的显著改善，57.9%的患者EASI评分降低≥75%。结论：这些结果表明HY-072808作为一种有效且耐受性良好的轻中度AD治疗药物的潜力，提示进一步的临床开发用于青少年和成人患者。试验注册：中国临床试验注册中心ChiCTR2400087123)。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Expert opinion on investigational drugs 医学-药学

CiteScore

10.00

自引率

0.00%

发文量

审稿时长

6-12 weeks

期刊介绍： Expert Opinion on Investigational Drugs (ISSN 1354-3784 [print], 1744-7658 [electronic]) is a MEDLINE-indexed, peer-reviewed, international journal publishing review articles and original papers on drugs in preclinical and early stage clinical development, providing expert opinion on the scope for future development. The Editors welcome: Reviews covering preclinical through to Phase II data on drugs or drug classes for specific indications, and their potential impact on future treatment strategies Drug Evaluations reviewing the clinical and pharmacological data on a particular drug Original Research papers reporting the results of clinical investigations on agents that are in Phase I and II clinical trials The audience consists of scientists, managers and decision-makers in the pharmaceutical industry, and others closely involved in R&D.