▎WuXi AppTec Content Team Report

On October 10, MindRank announced that the company's self-developed AI-assisted designGLP-1RA Small Molecule Oral New DrugMDR-001 Completes First Dose Group Administration in Phase 2b Clinical Trial. According to a press release from MindRank, this marks the official entry of the MDR-001 project into the registrational clinical research stage.

Public information shows,MDR-001 is a β-arrestin 2 highly selective GLP-1R agonist developed by MindRank. It is reported that,This drug not only retains the β-arrestin recruitment-induced islet cell repair and protection functions but also avoids the restricted insulin secretion and mediated endocytic desensitization caused by β-arrestin 1 recruitment., with distinct differentiation characteristics and potential clinical advantages.

As of now, the Phase 1b/2a trial of MDR-001 has been fully completed.The results show,After taking the product for 12 weeks, the subjects' average weight decreased by 9.0% (placebo 2.1%)., with an average decrease of 6.9% after placebo deduction, among which87% of 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 commonly reported adverse events during the treatment period were mild to moderate gastrointestinal adverse events.

This randomized, double-blind, placebo-controlled multicenter Phase 2b clinical 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 3 clinical trial.This study is led by Professor Linong Ji from Peking University People's Hospital and jointly conducted by 19 centers in China, planning to enroll a total of 300 adult subjects who are overweight or obese.

[1] MindRank's Oral Small Molecule GLP-1RA Phase IIb Clinical Study Completes First Dose Group Administration. Retrieved Oct 10, 2024, from https://mp.weixin.qq.com/s/oW6bK7KX1udkpVXaAQqyjA