• MDR-001 progressed from program discovery to Phase III in just 4.5 years, much faster than traditional development cycles.
• Phase IIb data demonstrated 10.3% mean weight reduction at Week 24 with a best-in-class safety potential (0.8% TEAE-related discontinuation rate).
• MDR-001’s unique biased-selective mechanism and metabolic benefits beyond weight loss.
  
  

MindRank, a clinical-stage artificial intelligence (AI)-empowered drug discovery company, announced the initiation of "MOBILE," a pivotal Phase III clinical trial evaluating its lead candidate, MDR-001. MDR-001 is a proprietary, orally available GLP-1 receptor agonist (GLP-1RA) for chronic weight management, developed using the company's Molecule Pro™ AI platform.

This milestone marks a paradigm shift in pharmaceutical development: MDR-001 is one of the first AI-designed molecules to reach Phase III, achieving this stage in just 4.5 years—validating the efficiency of MindRank's proprietary discovery engine.

The Phase III MOBILE trial is led by Professor Linong Ji, Director of Endocrinology and Metabolism department at Peking University People's Hospital and the Leading Principal Investigator for the MDR-001 clinical program.

"As a biased-selective GLP-1 receptor agonist, MDR-001 not only promotes cAMP messenger release when acting on the GLP-1 receptor but also selectively recruits beta-arrestin 2," remarked Professor Linong Ji. "In the 24-week study, it demonstrated excellent weight loss efficacy while providing additional benefits in uric acid reduction and hepatic function measures improvement. The MDR-001 group showed a mean uric acid reduction of 57.7 µmol/L, and hepatic function measures improved substantially across the non-placebo population. With no heart rate increased was reported throughout the trial, we look forward to further confirming these differentiated advantages in Phase III clinical study."

"Entering Phase III with MDR-001 is a validation of the AI-first approach to drug discovery," said Zhangming Niu, Founder and CEO of MindRank. "By leveraging our AI computing engine, our team identified a molecule with unique biology and a safety profile faster than traditional methods allow. We are now focused on executing this pivotal trial to bring a convenient, oral weight-loss option to patients globally."

Phase III MOBILE Trial Design
The MOBILE study serves as a pivotal study following positive Phase IIb data. It aims to enroll approximately 750 participants with overweight or obesity in China to evaluate 52-week efficacy and safety of MDR-00.

Summary of Phase IIb Results (n=317):

• Significant Efficacy: Participants achieved a mean weight reduction of 10.3% after 24 weeks of treatment.
• Favorable Safety Profile: Utilizing an 8-week rapid titration strategy, no drug-related serious adverse events (SAEs) occurred.
• Low Discontinuation: The discontinuation rate due to treatment-emergent adverse events (TEAEs) was only 0.8%.
• Cardiometabolic Improvements: Improvements were observed in hepatic function measures, waist circumference, blood pressure, lipid profiles, FPG and HbA1c, with a significant reduction in uric acid reduction.