HUADONG MEDICINE has announced positive results from Phase I clinical trials of HDM1002, its innovative oral small molecule GLP-1 receptor agonist, marking a significant milestone in the development of oral diabetes and weight management therapies. The trials, conducted through the company's wholly-owned subsidiary Hangzhou Zhongmei HuaDong Pharmaceutical CO. LTD, demonstrated favorable safety, tolerability, and efficacy signals across multiple dose ranges.
Phase Ia Trial Demonstrates Linear Pharmacokinetics and Glucose Control
The Phase Ia trial was a randomized, double-blind, placebo-controlled study that enrolled 79 healthy adult subjects to evaluate single-dose, escalating oral administrations of HDM1002. The study examined doses ranging from 10mg to 600mg, revealing linear pharmacokinetics across this entire range. All adverse events were graded as 1 or 2, indicating mild severity.
A key finding was the significant reduction in postprandial blood glucose levels in healthy subjects after a single dose compared to placebo, with the effect showing a clear dose-dependent relationship. The study also confirmed that high-fat meals had no impact on HDM1002's pharmacokinetics, suggesting consistent absorption regardless of food intake.
Phase Ib Trial Shows Promising Weight Loss Results
The Phase Ib trial enrolled 60 overweight and obese adult subjects in a randomized, double-blind, placebo-controlled design to assess multiple-dose administrations over 28 days. Subjects received doses ranging from 50-400mg daily, with the study evaluating safety, tolerability, pharmacokinetics, and pharmacodynamics.
After 28 days of continuous dosing, HDM1002 maintained good safety and tolerability profiles. The most common adverse events were gastrointestinal-related, primarily mild nausea and vomiting. Notably, subjects receiving 100mg or higher doses demonstrated significantly better weight loss compared to the placebo group on day 28, with effects showing dose-dependency.
The weight loss results were particularly encouraging, with subjects in the target dose range achieving average weight reductions of 4.9% to 6.8% from baseline by day 28. This level of weight loss in such a short timeframe suggests potential for meaningful clinical benefit in longer-term studies.
Novel Oral GLP-1 Receptor Agonist with Global IP Rights
HDM1002 represents an innovative approach to GLP-1 receptor activation, being developed as an orally active, potent, and highly selective small molecule full agonist. Unlike current injectable GLP-1 receptor agonists, this oral formulation could offer improved patient convenience and compliance.
Preclinical studies have demonstrated HDM1002's ability to potently activate the GLP-1 receptor and induce cAMP production. The compound has shown strong effects in improving glucose tolerance, reducing blood sugar, and promoting weight loss while maintaining good safety profiles in animal models.
Regulatory Progress and Development Timeline
The development program has achieved several regulatory milestones. HDM1002's IND application for diabetes treatment received approval in both China and the United States in May 2023. The weight loss indication IND application was subsequently approved in China in September 2023.
The company has maintained an aggressive development timeline, completing enrollment of all subjects for Phase II trials in China by May 2024. This rapid progression from Phase I to Phase II enrollment demonstrates the company's commitment to advancing this potentially transformative therapy.
HDM1002 is being developed by Zhongmei HuaDong with global intellectual property rights, positioning the company to potentially compete in the rapidly expanding GLP-1 receptor agonist market with a differentiated oral formulation that could address current limitations of injectable therapies.
