HUADONG MEDICINE Announces Positive Phase I Results

HUADONG MEDICINE Announces Positive Phase I Results

By, Admin 28 June 2024

HUADONG MEDICINE Announces Positive Phase I Results for Innovative Oral Small Molecule GLP-1 Receptor Agonist HDM1002

Overview

HUADONG MEDICINE, through its wholly-owned subsidiary Hangzhou Zhongmei HuaDong Pharmaceutical CO. LTD (Zhongmei HuaDong), has recently announced positive results from Phase I clinical trials of its innovative oral small molecule GLP-1 receptor agonist HDM1002 in China.

Phase Ia Trial of HDM1002

  • The Phase Ia trial of HDM1002 in China was a randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, and pharmacokinetics of single-dose, escalating oral administrations of HDM1002 in healthy adult subjects. 
  • Total 79 healthy subjects were enrolled. The results showed linear pharmacokinetics within the dose range of 10mg to 600mg for HDM1002, demonstrating good safety and tolerability. 
  • The adverse events were all graded as 1 or 2. Postprandial blood glucose levels were significantly reduced in healthy subjects after a single dose compared to the placebo, exhibiting a dose-dependent effect. 
  • High-fat meals had no impact on the pharmacokinetics of HDM1002.

Phase Ib Trial

  • The Phase Ib trial of HDM1002 in China was a randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple-dose, escalating oral administrations of HDM1002 in overweight and obese adult subjects. 
  • Total 60 subjects were enrolled. After 28 days of continuous dosing within the dose range of 50-400mg, HDM1002 demonstrated good safety and tolerability. 
  • The most common adverse events were gastrointestinal-related, mostly mild nausea and vomiting. 
  • Subjects in the 100mg or higher dose groups showed significantly better weight loss compared to the placebo group on day 28, exhibiting a dose-dependent effect. 
  • Subjects in the target dose range achieved an average weight loss of 4.9% to 6.8%1 from baseline by day 28.

1.  Least Squares Means, the Estimates from Mixed Models for Repeated Measures

About HDM1002 Tablet

  • HDM1002 is an innovative small molecule drug independently developed by Zhongmei HuaDong with global intellectual property rights. 
  • It is an orally active, potent, and highly selective small molecule full agonist of the GLP-1 receptor. 
  • Preclinical studies have shown that HDM1002 can potently activate the GLP-1 receptor, induce the production of cAMP, and exhibit strong effects in improving glucose tolerance, reducing blood sugar, promoting weight loss, demonstrating good safety.

IND Application Approval

  • HDM1002's IND application for the treatment of diabetes was approved in both China and US in May 2023. 
  • The IND application for the weight loss indication was approved in China in September 2023. 
  • In May 2024, the enrollment of all subjects for Phase II in China was completed.