HUADONG MEDICINE Reports Positive Phase I Results for Oral GLP-1 Agonist HDM1002

HANGZHOU, China, June 26, 2024 -- HUADONG MEDICINE, through its wholly-owned subsidiary Hangzhou Zhongmei HuaDong Pharmaceutical CO. LTD (Zhongmei HuaDong), has recently unveiled promising Phase I clinical trial results for their innovative oral small molecule GLP-1 receptor agonist, HDM1002, conducted in China.

The Phase Ia trial, aimed at assessing the safety, tolerability, and pharmacokinetics of single escalating oral doses of HDM1002, was a randomized, double-blind, placebo-controlled study. It involved 79 healthy adult participants. The data revealed linear pharmacokinetics across dosages ranging from 10mg to 600mg, indicating the treatment's good safety and tolerability profile. Adverse events reported were mild, rated as grade 1 or 2. Importantly, the trial demonstrated significant reductions in postprandial blood glucose levels in those receiving HDM1002 compared to the placebo, with these effects being dose-dependent. Furthermore, high-fat meals did not influence the pharmacokinetics of HDM1002.

The Phase Ib trial expanded the investigation to multiple escalating doses of HDM1002 in overweight and obese adults, maintaining the randomized, double-blind, placebo-controlled study design. A cohort of 60 subjects participated in this phase, receiving continuous treatments within a dose range of 50mg to 400mg over 28 days. The findings reaffirmed the drug’s positive safety and tolerability profile, with gastrointestinal issues such as mild nausea and vomiting being the most common adverse events. Notably, subjects administered doses of 100mg or higher experienced significant weight loss compared to the placebo group by day 28, with weight reductions ranging from 4.9% to 6.8% from baseline.

HDM1002 Tablet is a groundbreaking small molecule drug developed independently by Zhongmei HuaDong, with global intellectual property rights. As an orally active, potent, and highly selective full agonist of the GLP-1 receptor, HDM1002 has shown substantial efficacy in preclinical studies. These studies highlight its ability to activate the GLP-1 receptor, increase cAMP production, improve glucose tolerance, lower blood sugar levels, and aid in weight reduction, all while maintaining a favorable safety profile.

The drug's Investigational New Drug (IND) application for diabetes treatment received approval in both China and the US in May 2023. Additionally, an IND application for weight loss was approved in China in September 2023. As of May 2024, the enrollment for Phase II trials in China has been completed.

These promising Phase I trial results support the potential of HDM1002 as a viable treatment option for diabetes and weight management, and pave the way for further clinical development and eventual market introduction.

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