Yunovia Gains MFDS IND Approval for Phase 1 MAD Study on GLP-1 Agonist

In a recent announcement from SEOUL, South Korea, Yunovia, a drug research and development subsidiary of Ildong Pharmaceutical Group, revealed that Korea's Ministry of Food and Drug Safety (MFDS) has given clearance for the Investigational New Drug (IND) application for the Phase 1 Multiple Ascending Dose (MAD) study of ID110521156. This small molecule GLP-1 agonist, which is intended for the treatment of obesity and diabetes, successfully completed its Phase 1 Single Ascending Dose (SAD) study prior to this approval.

The upcoming Phase 1 MAD study aims to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ID110521156 through repeated doses and incremental increases. In the earlier Phase 1 SAD study, Yunovia not only confirmed the drug’s efficacy in regulating insulin secretion and blood glucose levels but also demonstrated its superior tolerability in comparison to other drugs within the same category.

ID110521156 functions as a GLP-1 (glucagon-like peptide-1) receptor agonist, mimicking the role of the GLP-1 hormone. This hormone is crucial for insulin synthesis and secretion, reducing blood glucose levels, regulating gastrointestinal movements, and suppressing appetite. Yunovia's strategy for ID110521156, being a small molecule compound, is to develop it as an orally administrable medication. This differentiates it from the current standard GLP-1 treatments, which are typically peptide injections, offering advantages in manufacturability and ease of use.

A representative from Yunovia highlighted that ID110521156 stands out as the only small molecule-based new drug in the clinical stage among GLP-1 receptor agonists in Korea. Globally, it is among the more advanced developments in its class. The representative also emphasized that feedback from potential partner companies, gathered since the early stages of development, has been incorporated into the design of both the SAD and MAD studies. Yunovia plans to continue its dialogue with these partners as they advance the development of ID110521156 and pursue global out-licensing opportunities.

ID110521156 has shown promise as an orally available small molecule agonist of the GLP-1 receptor. Following the completion of the Phase 1 SAD study, which included a food effect study in July 2024, the drug was well tolerated and indicated potential for once-daily dosing with a sustained PK profile. The forthcoming 4-week MAD study will gather PD data, including continuous glucose monitoring and body weight changes as exploratory endpoints.

Yunovia, founded in 2023 as a spin-off from Ildong Pharmaceutical, aims to maximize the value of its global, innovative drug pipeline and enhance R&D productivity for faster drug development. The company’s R&D pipeline boasts over 20 innovative programs at various stages of development, targeting multiple therapeutic areas. With its focus on small molecule R&D and several clinical programs already underway, Yunovia is committed to becoming a leading innovator in life-changing therapeutics.