歌礼制药-B：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 announcement by the company regarding the positive topline results of the ASC50 Phase I clinical trial in the U.S. indicates significant advancements in the development of ASC50 as a targeted treatment for autoimmune and inflammatory diseases, particularly psoriasis [1][3]. Group 1: Clinical Trial Results - ASC50 demonstrated a favorable safety and tolerability profile in the single ascending dose (SAD) study, with all adverse events reported as mild (Grade 1) and of short duration, and no serious adverse events (SAEs) reported [2]. - 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 [2]. - ASC50 exhibited significant targeted binding effects, with elevated plasma IL-17A levels persisting up to 7 days post-administration at higher doses [2]. Group 2: Pharmacokinetics and Comparison - The pharmacokinetic characteristics of ASC50 were found to be dose proportional across the 10 mg to 600 mg dosing range [2]. - In head-to-head studies with LY4100511, ASC50 showed 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 binding effects, ASC50 has progressed to the next phase of clinical development in patients with mild to moderate plaque psoriasis [3]. - ASC50 is a novel chemical entity (NCE) with U.S. and global compound patent protection until 2043, excluding potential patent extensions, indicating strong commercial value in the market [3]. - The company emphasizes the potential of ASC50 as a best-in-class oral small molecule IL-17 inhibitor, developed using AI-assisted structure-based drug discovery technology [3].