China Silicon Intelligence (03696) has completed the first dose administration of GARUTADUSTAT (ISM5411) in the Phase II clinical trial named BETHESDA.

Engitix Intelligence (03696) announced that the company has completed the dosing of the first subject with its innovative PHD inhibitor ISM5411 in a phase IIa clinical trial named BETHESDA. The innovative candidate drug, developed with the assistance of the group's proprietary generative AI platform Pharma.AI, is intestinal-restricted and intended for the treatment of inflammatory bowel disease (IBD). Its generic name, Garutadustat, has recently been formally approved by the USAN Council. The ongoing multicenter, randomized, double-blind, placebo-controlled phase IIa clinical study, abbreviated as BETHESDA (Barrier Enhancement Therapy for Healing Enteric Structural Defects & Anomalies), is led by renowned expert in the field of digestive diseases and head of gastroenterology at the First Affiliated Hospital of Sun Yat-sen University, Professor Chen Minhu, as the Leading Principal Investigator (PI). The study plans to evaluate the clinical application potential of Garutadustat (generic name ISM5411) in approximately 80 patients with ulcerative colitis (UC), with a focus on safety, tolerability, pharmacokinetic (PK) characteristics, and exploring its effectiveness signal through multiple dimensions such as clinical relief/response, endoscopy, histopathology, and biomarkers. In addition, Engitix Intelligence has recently reached an external licensing cooperation with Taijing, focusing on another innovative candidate drug under the PHD project, ISM4808, for the treatment of anemia in chronic kidney disease (CKD). The total value of this external licensing cooperation amounts to tens of millions of US dollars, combining Taijing's clinical and market expertise with Engitix Intelligence's AI-driven drug development efficiency and precision, aiming to meet unmet medical needs. By integrating advanced AI and automation technology, Engitix Intelligence has significantly improved the efficiency of early-stage drug development in practical applications, setting a benchmark for AI-driven drug development. Compared to the average 4.5-year time cycle for traditional drug development, Engitix Intelligence's self-developed projects from 2021 to 2024 have an average time from initiation to PCC nomination of only 12-18 months, with each project requiring synthesis and testing of approximately 60-200 molecules.