AI-Designed Oral GLP-1 Receptor Agonist MDR-001 Enters Phase IIa Clinical Trial for Obesity and Type 2 Diabetes
MindRank
AI Drug Developer
On September 8, AI drug discovery company MindRank announced that its self-developedMindRank's GLP-1RA Small Molecule Oral Drug MDR-001 Successfully Completes First Dose Group Administration in Phase IIa Clinical Trial for Obese Subjects。
This trial is a Phase I clinical study that is double-blind, randomized, placebo-controlled, and dose-escalation, with subjects including healthy adult volunteers, obese/overweight individuals, and Type II diabetes patients.
MDR-001
MDR-001 is MindRank's first self-developed Molecule Pro one-stop solution.AI-Driven Drug Discovery Platform-Assisted DesignThe innovative pipeline belongs to a β-arrestin 2 highly selective GLP-1 receptor agonist.
This drug not only retains the islet cell repair and protection functions brought by β-arrestin recruitment but also avoids the restricted insulin secretion and mediated endocytic desensitization caused by β-arrestin 1 recruitment.
Preclinical study data show that, compared with similar drugs in clinical research, MDR-001 has equivalent or slightly superior efficacy in vivo and in vitro, and its drug-likeness (including PK and safety window) has significantly improved.
Meanwhile, in the early-stage diabetic and obese monkey efficacy model with long-term administration: In addition to effectively reducing blood glucose and body weight, MDR-001 also restored HbA1c to the level of healthy monkeys. No rebound occurred during the recovery period after drug withdrawal, suggesting that MDR-001 may help repair damaged islet cells and restore islet function, demonstrating the potential to cure early-stage diabetes.
In November last year, MindRank formally submitted to the U.S. Food and Drug Administration (FDA) the Investigational New Drug (IND) application for MDR-001 indicated for Type 2 diabetes and weight loss, which has been accepted.
In February 2023, MDR-001 was submitted for clinical trials in China, intended for the treatment of type 2 diabetes and weight loss.
MDR-001 administered the first subject in its Phase I clinical trial in the first half of 2023 and has now preliminarily completed the Phase I Single Ascending Dose (SAD) study.
Preliminary clinical research results show that MDR-001 has good safety and pharmacokinetic characteristics, with a clear linear relationship across different dose groups, and its preclinical feature advantages have been well translated into clinical practice.
Originated in London, UK
MindRank, established in 2020, is an AI-driven innovative drug discovery company. The founder, Zhangming Niu, has over a decade of overseas study and work experience, while the scientific research is led by a Fellow and Vice Chancellor from the University of Cambridge.
The company team includes senior medicinal chemists.Experts, molecular biologists, and AI drug discovery specialistsHome, Team MembersThe staff have successfully identified 16 targets and led multiple drug pipelines into clinical trials, some of which have been marketed.Core AI Member OnceRanked in the top 10 in multiple global AI competitions and won the championship in the world's genetic engineering competition.
MindRankMindRank has a one-stop AI-driven drug discovery platform — the knowledge graph-based data mining platform PharmKG™, the protein dynamics simulation and structure prediction platform Molecule Dance™, and the drug design platform Molecule Pro™.
The AI pharmaceutical solutions of the company were rated as one of the "11 most important AI drug R&D breakthrough achievements globally from 2018 to 2020" by the authoritative European and American institution, Deep Pharma Intelligence.
Currently, the company has partnered with multiple listed pharmaceutical enterprises andOneTop 10 global pharmaceutical companies have established technical R&D or drug R&D commercial cooperation partnerships, signing drug pipeline cooperation orders totaling over hundreds of millions of dollars, with multiple projects successfully delivered.
In May 2021, MindRank completedAngel Round Financing of 45 Million Yuan, led by the Sherpa Healthcare Fund.
In December 2021, MindRank completed another roundTens of Millions of Dollars in Series A Financing, led by Huagai Capital and Songhe Capital, with continued investment from existing shareholder Sherpa Capital.
On July 18, 2023, MindRank announced the completion of over$20 Million A+ Round FinancingLed by Chenow Investment, the rest of the investors include several well-known investment institutions from the life sciences and healthcare sectors.
Last but not least
Currently, there are approximately 537 million adults with diabetes and about 650 million people with obesity worldwide.
The global GLP-1 receptor agonist drug market size reached$13.1 billion, which is expected to grow to by 2030$40.7 billion。
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.
Small-molecule GLP-1 receptor agonist MDR-001 shows preclinical efficacy similar to peptides, with a higher safety window, no immunogenicity, oral convenience, low cost, and ease of storage and portability, offering the potential for better treatment outcomes for diabetes and obesity patients.
Other Chinese pharmaceutical companies布局oral small molecule GLP-1R agonists include RuiGe Medicine, Huadong Medicine, and Salubris, among which RuiGe Medicine's RGT-075 and Huadong Medicine's TTP273 have both entered Phase II clinical trials.
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