On October 10, AI pharmaceutical companyMindRankAnnounced that its self-developed AI-assisted designed GLP-1RA small molecule oral drugMDR-001 Completes Dosing of First Cohort in Phase IIb Clinical Trial。 This randomized, double-blind, placebo-controlled multicenter clinical Phase IIb study aims to further evaluate the efficacy and safety of long-term administration of the oral small molecule MDR-001 tablets in overweight or obese subjects, providing a basis for dose selection in the subsequent Phase III clinical trial. This study is led by Professor Li-Nong Ji from Peking University People's Hospital, jointly conducted by 19 centers across China, and plans to enroll a total of 300 adult subjects who are overweight or obese. MDR-001 completed the Phase I clinical single-dose escalation trial in the first half of 2023 and initiated the Phase Ib/IIa dose-finding study in September 2023. As of now, the Ib/IIa phase trial has been fully completed, showing that: after taking MDR-001 for 12 weeks, the average weight of the subjects decreased by 9.0% (placebo 2.1%), with an average decrease of 6.9% after placebo deduction, and 87% of the subjects lost more than 5% of their body weight. Meanwhile, MDR-001 demonstrated good safety and tolerability, with no serious adverse events reported. No participants withdrew due to adverse events, and the maximum tolerated dose acceptable to patients was far from reached. The most frequently reported treatment-related adverse events were mild to moderate gastrointestinal issues. The launch of this multi-center Phase IIb clinical trial marks the official entry of the MDR-001 project into the registrational clinical research stage, which will accelerate the provision of better treatment options for patients both in China and internationally. Currently, GLP-1-targeted therapies are experiencing excessive internal competition.According to the Dingxiangyuan Insight database, as of 2023, there are a total of 289 projects worldwide targeting the GLP-1 receptor (from preclinical to approved and marketed), including 27 ongoing clinical projects for GLP-1-based obesity treatment drugs. Currently marketed GLP-1R agonists, such as semaglutide and liraglutide developed by Novo Nordisk, are mostly peptide-based injectable drugs, and there are no small-molecule GLP-1R agonists available on the market yet. Other Chinese pharmaceutical companies布局oral small molecule GLP-1R agonists include MindRank, Huadong Medicine, and Salubris, among which MindRank's RGT-075 and Huadong Medicine's TTP273 have both entered Phase II clinical trials. MindRank, established in 2020, is an AI-driven innovative drug discovery company. The core team comes from leading pharmaceutical companies in China and abroad as well as top international AI drug discovery firms. The founder, Zhangming Niu, has over a decade of overseas study and work experience, while the research is led by a Cambridge University vice-chancellor and academician. The company's latest round of financing was completed in July 2023.$20 Million A+ RoundFinancing, led by Xenovation. —The End— Recommended Reading
