MindRank Reports Positive Phase 2b Results for AI-Designed Oral Obesity Drug MDR-001, Showing Significant Weight Loss and Metabolic Improvements

MindRank, a clinical-stage AI-powered drug discovery company, has announced positive topline results from a Phase 2b clinical trial of its proprietary AI-designed oral GLP-1 receptor agonist (GLP-1RA), MDR-001, for adults with obesity or overweight in China. The 24-week, randomized, placebo-controlled study demonstrated significant and dose-dependent weight reduction, with participants receiving MDR-001 achieving mean body weight reductions ranging from 8.2% to 10.3% (7.4 to 9.2 kg). In contrast, the placebo group saw a mean reduction of only 2.5% (2.4 kg). Placebo-adjusted weight loss ranged from 7.1% to 7.8%, with 70.9% to 85.4% of participants achieving at least 5% weight loss and 34.5% to 48.1% achieving at least 10%. In addition to weight reduction, MDR-001 showed significant improvements in key cardiometabolic markers, including waist circumference, blood pressure, and lipid profiles. This suggests its potential as a comprehensive metabolic therapy. MDR-001 was well-tolerated, with no treatment-related serious adverse events (SAEs) reported. The most common side effects were mild to moderate gastrointestinal symptoms, such as nausea, vomiting, and diarrhea, which primarily occurred during the initial 6-week dose-escalation period and resolved quickly, typically within 1 to 5 days. Hepatic safety analyses revealed no evidence of transaminase elevation, even among approximately 20% of participants with pre-existing liver impairment. In fact, ALT and AST levels were significantly reduced in the MDR-001 treatment groups compared to the placebo. Additionally, no clinically relevant increases in heart rate were observed, and the overall discontinuation rate due to side effects was just 0.8%. Professor Linong Ji, the leading principal investigator of the study and Director of Endocrinology and Metabolism at Peking University People's Hospital, praised the results, noting that MDR-001's oral formulation and favorable safety profile make it a strong candidate for long-term obesity management. Dr. Zhangming Niu, Founder and CEO of MindRank, emphasized that the Phase 2b data validate the company's AI-driven drug discovery engine and internal development capabilities. MindRank is now preparing for global Phase 3 trials and exploring once-daily dosing regimens to enhance patient convenience. MDR-001 is a novel, β-arrestin 2 selective, orally bioavailable small-molecule GLP-1RA discovered using MindRank's proprietary AI platform, Molecule Pro™. This platform, along with others like PharmKG™ and Molecule Dance™, aims to accelerate the drug discovery process and deliver innovative small molecule medicines. The compound has shown excellent functional potency and selectivity, with favorable ADME (absorption, distribution, metabolism, excretion) properties and desirable pharmacokinetics, safety, and tolerability, suggesting its best-in-class potential for treating obesity and Type 2 Diabetes Mellitus (T2DM). The Phase 2b trial (NCT06606483) involved 317 adult participants across 19 clinical sites in China. Participants were either overweight with at least one weight-related comorbidity or obese with inadequate response to lifestyle interventions. They received twice-daily doses of MDR-001 at 90 mg, 120 mg, 150 mg, or 180 mg, or a matching placebo, over 24 weeks. The primary efficacy endpoint was the percent change in body weight from baseline at Week 24. Industry insiders view these results as a significant milestone for AI-driven drug discovery, highlighting the potential of AI to revolutionize the pharmaceutical sector. MindRank’s success with MDR-001 not only advances the field but also positions the company as a leader in developing novel treatments for metabolic disorders, which have large unmet medical needs. The positive outcomes are expected to attract further investment and collaborations, helping to address the global obesity epidemic more effectively. MindRank, based in Hangzhou, China, and London, UK, continues to leverage its AI platforms to expedite drug discovery and deliver clinically beneficial treatments. For more information, visit www.mindrank.ai, and for business development inquiries, contact bd@mindrank.ai.