INSILICO (03696) completed the dosing of the first subject in the Phase IIA clinical trial named BETHESDA for GARUTADUSTAT (ISM5411).

INSILICO (03696) announced that the company has completed the first dosing of its innovative PHD inhibitor ISM5411 in a Phase IIa clinical trial named BETHESDA. This innovative candidate drug was developed with the assistance of the group's self-generated AI platform Pharma.AI and is intended for the treatment of inflammatory bowel disease (IBD) with intestinal restriction. The drug, with the generic name Garutadustat, was recently 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 Professor Chen Minhui, a renowned expert in the field of digestive diseases in China and head of the Department of Gastroenterology at the First Affiliated Hospital of Sun Yat-sen University. The study plans to evaluate the clinical application potential of Garutadustat (formerly known as ISM5411) in approximately 80 patients with ulcerative colitis (UC), focusing on safety, tolerability, pharmacokinetic (PK) characteristics, and exploring efficacy signals through multidimensional indicators such as clinical remission/response, endoscopy, tissue pathology, and biomarkers. In addition, INSILICO recently entered into an external licensing partnership with Taijing to focus on another innovative candidate drug, ISM4808, under the PHD project for the treatment of chronic kidney disease (CKD)-related anemia. This external licensing partnership is valued at tens of millions of dollars and aims to meet unmet medical needs by combining Taijing's clinical and market expertise with INSILICO's AI-driven drug development efficiency and precision. By integrating advanced AI and automation technologies, INSILICO 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 time period of 4.5 years for traditional drug development, INSILICO's in-house projects from initiation to PCC nomination during 2021-2024 have an average time frame of only 12-18 months, with each project requiring the synthesis and testing of approximately 60-200 molecules.