Core Viewpoint - The company, 英矽智能 (03696.HK), has initiated the first dosing of its innovative PHD inhibitor ISM5411 in a Phase IIa clinical trial named BETHESDA, aimed at treating inflammatory bowel disease (IBD) [1] Group 1: Clinical Trial Details - The BETHESDA trial is a multi-center, randomized, double-blind, placebo-controlled study [1] - The trial is led by Professor Chen Minhu, a prominent expert in gastroenterology from Sun Yat-sen University First Affiliated Hospital [1] - Approximately 80 patients with ulcerative colitis (UC) will be evaluated for the clinical application potential of Garutadustat (formerly ISM5411) [1] Group 2: Drug Development and Approval - Garutadustat has recently received official approval from the USAN Council for its generic name [1] - The drug is developed using the company's proprietary generative AI platform, Pharma.AI, and is characterized by its intestinal restriction [1] Group 3: Evaluation Metrics - The trial will assess safety, tolerability, and pharmacokinetic (PK) characteristics of Garutadustat [1] - Effectiveness signals will be explored through multiple indicators, including clinical remission/response, endoscopic examination, histopathology, and biomarkers [1]
英矽智能(03696.HK)：于BETHESDA的IIA期临床试验中完成GARUTADUSTAT (ISM5411)首例受试者给药