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Here's an update from YUNOVIA.

Press release

Yunovia Receives KFDA IND Approval for ‘GLP-1 Analog’

  • 2024.09.03
  • 172

Ildong Pharmaceutical Group’s Yunovia Receives KFDA IND Approval for ‘GLP-1 Analog’
Commencement of Phase 1 Follow-up MAD Trial to Evaluate Safety and Pharmacological Properties
Development of an Oral Synthetic Drug Based on Low Molecular Weight Compounds, Distinct from Peptide Injection Therapies

 

 

Ildong Pharmaceutical Group's new drug research and development company, Yunovia (CEO Lee Chae Joon), announced on the 26th that it has initiated the Multiple Ascending Dose (MAD) phase of its Phase 1 clinical trial for its metabolic disease drug candidate ‘ID110521156,’ targeting diabetes and obesity.

On the 20th, Yunovia received approval from the Korea Food & Drug Administration (KFDA) for the Investigational New Drug (IND) application for ID110521156. This follow-up Phase 1 study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics through repeated dosing and dose escalation.

Previously, Yunovia confirmed the efficacy of ID110521156 in insulin secretion and blood glucose control, as well as superior safety compared to other drugs in the same class through preclinical efficacy and toxicity evaluations. Promising drug characteristics were also observed in the recently completed Phase 1 Single Ascending Dose (SAD) study, yielding positive results.

ID110521156 is a glucagon-like peptide-1 receptor agonist (GLP-1 receptor agonist) that mimics the role of the GLP-1 hormone in the body, including insulin synthesis and secretion, blood glucose reduction, gastrointestinal motility regulation, and appetite suppression.

Notably, ID110521156 is based on a low molecular weight compound. The company plans to develop it as an oral synthetic drug with distinct advantages in production efficiency and user convenience compared to existing peptide injection therapies for diabetes and obesity.

A representative from Yunovia emphasized, “Currently, ID110521156 is the only synthetic drug in the GLP-1 receptor agonist class that has entered clinical stages in Korea, and it is among the leading groups in terms of development progress on a global scale.”

He further stated, “We designed the SAD and MAD clinical trial protocols with input from global big pharma partners, considering the needs of the ‘GLP-1’ market. We plan to actively pursue global licensing-out opportunities alongside continuous clinical development of ID110521156.”

 

Original press release was made only in Korean by Ildong Pharm and this translated version was provided by Yunovia later for viewers' convenience.