歌礼制药-B(01672)：有望成为同类最佳口服小分子IL-17抑制剂ASC50美国I期研究取得积极的顶线结果

Core Viewpoint - The article highlights the positive topline results of ASC50, a novel oral small molecule IL-17 inhibitor developed by the company, from a Phase I clinical trial in the United States, indicating its potential as a best-in-class treatment for psoriasis and other autoimmune diseases [1][2][3] Group 1: Clinical Trial Results - ASC50 demonstrated a favorable safety profile and tolerability in a randomized, double-blind, placebo-controlled Phase I trial involving 46 healthy subjects [1] - The elimination half-lives of ASC50 after single oral doses of 10 mg, 30 mg, 100 mg, 200 mg, 400 mg, and 600 mg were 43, 89, 91, 87, 104, and 85 hours respectively, supporting the potential for once-daily or possibly once-weekly dosing [1][2] - ASC50 exhibited significant target engagement, with elevated plasma IL-17A levels persisting up to 7 days post-administration at higher doses [2] Group 2: Pharmacokinetics and Comparison - ASC50 showed dose-proportional pharmacokinetic characteristics across the 10 mg to 600 mg dosing range [2] - In head-to-head studies with LY4100511, ASC50 demonstrated higher absolute oral bioavailability, greater drug exposure, longer half-life, and lower clearance rates [2] Group 3: Future Development and Market Potential - Based on the positive safety, tolerability, pharmacokinetics, and significant target engagement, ASC50 is advancing to the next phase of clinical development in patients with mild to moderate plaque psoriasis [2] - ASC50 is a new chemical entity (NCE) with patent protection in the U.S. and globally until 2043, excluding potential patent extensions, indicating strong commercial value [3] - The company emphasizes the encouraging data and the differentiated pharmacokinetic profile of ASC50, positioning it as a potential best-in-class oral small molecule IL-17 inhibitor [3]