速递｜德睿智药AI辅助设计口服小分子减重药 MDR-001 启动 III 期临床

Core Viewpoint - The article discusses the launch of the Phase III clinical trial for MDR-001, an AI-assisted designed GLP-1 receptor agonist, highlighting its potential for weight loss and safety profile [5][8]. Group 1: Clinical Trial Details - The Phase III clinical trial, named MOBILE, aims to recruit approximately 750 overweight or obese participants and will evaluate the drug's efficacy and safety over a 52-week period [5]. - The Phase IIb trial results showed a significant weight reduction of 10.3% after 24 weeks of treatment among 317 participants with a baseline weight of 90 kg [6]. Group 2: Safety and Efficacy - The trial reported no serious adverse events related to the drug, with a treatment discontinuation rate due to adverse events of only 0.8% [7]. - Improvements were observed in various cardiovascular and metabolic parameters, including a significant reduction in uric acid levels by 57.7 µmol/L (P<.00001) and notable improvements in liver function indicators [7][8]. Group 3: Expert Insights - Professor Ji Linong, a key researcher, emphasized the unique mechanism of MDR-001, which not only promotes cAMP release but also selectively recruits β-arrestin2, contributing to its weight loss efficacy and additional benefits in uric acid and liver function [8]. - CEO Niu Zhangming highlighted the rapid progression of MDR-001 to Phase III trials as a significant milestone for the company and a breakthrough in AI-driven drug development [8]. Group 4: Company Achievements - Since 2021, the company has developed over 10 proprietary research pipelines and nominated 7 clinical candidates, with two receiving clinical trial approvals [8]. - The company has published numerous influential peer-reviewed papers in leading journals, showcasing its commitment to advancing the field of drug development [8].