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10th October 2024 - MindRank, a‘Drexel Pharmaceuticals’company focused on the use of Artificial Intelligence to drive new drug discovery and development, announced the completion of the first dose group dosing of its in-house AI-assisted design of a new oral small molecule GLP-1RA drug, MDR-001, in a Phase IIb clinical trial. This randomised, double-blind, placebo-controlled, multi-centre clinical Phase IIb study was designed to further evaluate the efficacy and safety of long-term administration of oral small molecule MDR-001 tablets in overweight or obese subjects, and to provide a basis for dose selection for the next Phase 3 clinical study to be conducted. The study is led by Professor Ji Linong of the People's Hospital of Peking University in collaboration with nineteen centres across China, and is planned to enroll a total of 300 adult overweight or obese subjects.MDR-001 will complete the Phase I clinical single-dose ramp-up trial in the first half of 2023, and the Phase Ib/IIa dose exploration study will be conducted in September 2023.MDR-001 will be administered in the first half of this year. The Phase Ib/IIa trial has been fully completed as of today, and the results show that subjects lost an average of 9.0% of their body weight (2.1% for placebo) after 12 weeks of MDR-001, and an average of 6.9% of their body weight after placebo deduction, with 87% of the subjects losing more than 5% of their body weight. Meanwhile, MDR-001 demonstrated a good safety and tolerability profile, with no serious adverse events, no subjects withdrew due to adverse events, and well below the maximum tolerable dose acceptable to patients. The most commonly reported treatment-phase adverse events were mild to moderate gastrointestinal adverse events. The initiation of this multi-centre Phase IIb clinical trial marks the formal entry of the MDR-001 project into the stage of registered clinical research, which will accelerate the provision of better treatment options for domestic and foreign patients.

▎About MDR-001

MDR-001 is an innovative drug pipeline designed with the aid of Drexel's own Molecule Pro™ one-stop AI drug discovery platform. The results of clinical studies show that MDR-001 has a good safety and pharmacokinetic profile, with a clear linear relationship between different dosage groups, and its preclinical profile translates well into the clinic.

▎About Drexel Pharma

Dreyfus Pharmaceuticals is a clinical-stage AI-driven innovative drug discovery and development company. The company's vision is to continuously deliver differentiated and clinically valuable drug candidates through the penetration and integration of multiple cutting-edge technologies in AI and new drug discovery and development, so that more lives can be brought back to health. The company's AI pharmaceutical solutions have been recognised by Deep Pharma Intelligence as one of the world's top 11 AI drug discovery breakthroughs for 2018-2020, and was named to Forbes' “Asia 100 to Watch” list in 2023. In 2023, Forbes named the company to its ‘Forbes Asia 100 to Watch’ list, with only 11 startups from mainland China on the list, and in 2024, the company was named to Fortune Magazine's IMPACT list of ‘China's Most Socially Influential Startups’.