MindRank Announces U.S. FDA Clearance of IND Application for MDR-001, a Novel GLP-1 Receptor Agonist for the Treatment of Type 2 Diabetes and Obesity

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MindRank expects to initiate a Phase I safety study in the first quarter of 2023.

Metadata

Provider:

PR Newswire

Retrieved on:

Monday, December 26, 2022

Information

Tags:

Molecule, Food, Obesity, Intelligence, T2DM, FDA, Investigational New Drug, ADME, IND, Pharmacokinetics, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Pharmaceutical industry, Medical device

Geotags:

CHINA, INDIANA, CALIFORNIA

⚠ generated by AI ↴

Organisation:

MINDRANK, MDR-001

Summary

Key Points:

MindRank expects to initiate a Phase I safety study in the first quarter of 2023.
Empowered by Mindrank's proprietary AI drug discovery platform, Molecule Pro™, it just took the company 19 months to obtain the IND approval since the MDR-001 program was initiated.
"By facilitating novel small molecule drug design with desired drug-like properties, we believe our AI platform can significantly improve the pre-clinical R&D efficiency.
The FDA IND approval of MDR-001 is a solid validation for the potential of our AI platform."

MindRank Announces U.S. FDA Clearance of IND Application for MDR-001, a Novel GLP-1 Receptor Agonist for the Treatment of Type 2 Diabetes and Obesity

SHANGHAI and HANGZHOU, China, Dec. 26, 2022 /PRNewswire/ -- MindRank, an artificial intelligence (AI)-empowered drug discovery company, announces today that the U.S. Food and Drug Administration (FDA) has cleared the company's Investigational New Drug (IND) application for MDR-001, an oral small-molecule glucagon-like peptide 1 receptor agonist (GLP-1 RA), for the treatment of obesity and type 2 diabetes mellitus (T2DM), respectively. MindRank expects to initiate a Phase I safety study in the first quarter of 2023.

Empowered by Mindrank's proprietary AI drug discovery platform, Molecule Pro™, it just took the company 19 months to obtain the IND approval since the MDR-001 program was initiated. With fewer than 100 chemical compounds synthesized and tested, the preclinical candidate was discovered.

"By facilitating novel small molecule drug design with desired drug-like properties, we believe our AI platform can significantly improve the pre-clinical R&D efficiency. The FDA IND approval of MDR-001 is a solid validation for the potential of our AI platform." commented Zhangming Niu, CEO of MindRank. This heralds the transition of MindRank from a discovery-stage to a clinical-stage AI-empowered biotechnology company.

About MDR-001

MDR-001 is a novel, orally bioavailable small-molecule GLP-1 RA discovered using MindRank's proprietary AI platform, Molecule Pro™. In the comprehensive preclinical studies, MDR-001 has demonstrated excellent functional potency and selectivity, with favorable ADME properties and oral bioavailability, as well as desirable pharmacokinetics and tolerability. MDR-001's superior preclinical efficacy and safety profiles indicate its best-in-class potential for Obesity and T2DM indications with large unmet medical needs.

About MindRank

MindRank is an artificial intelligence (AI)-empowered drug discovery company. By leveraging its proprietary AI platform, Molecule Pro, the company aims to significantly accelerate the drug discovery process and deliver small molecule drugs with desirable efficacy and safety profiles.

To learn more, visit www.mindrank.ai .

View original content:https://www.prnewswire.co.uk/news-releases/mindrank-announces-us-fda-clearance-of-ind-application-for-mdr-001-a-novel-glp-1-receptor-agonist-for-the-treatment-of-type-2-diabetes-and-obesity-301709954.html