Yunovia Announces IND Approval by the MFDS to Initiate Phase 1 MAD Study for the Small Molecule GLP-1 Agonist

SEOUL, South Korea, Aug. 27, 2024 /PRNewswire/ -- Yunovia, a drug R&D subsidiary of Ildong Pharmaceutical Group, announced on the 26th that the Ministry of Food and Drug Safety (MFDS) of Korea has cleared the IND application of Phase 1 Multiple Ascending Dose (MAD) study for ID110521156, an orally available small molecule GLP-1 agonist being developed for obesity and diabetes following the successful completion of the Phase 1 Single Ascending Dose (SAD) study.

Phase 1 MAD study will be conducted to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) characteristics of ID110521156 following repeated administration and stepwise increase in dose.

Previously, Yunovia not only confirmed the drug's effectiveness related to insulin secretion and blood glucose control, but also, its superior tolerability compared to other drugs in the same class through preclinical efficacy and toxicity evaluations in the recently completed Phase 1 SAD study.

ID110521156 is a GLP-1 (glucagon-like peptide-1) receptor agonist that plays the same role as the GLP-1 hormone which is involved in the synthesis and secretion of insulin in the body, reduction of blood glucose level, regulation of gastrointestinal tract movements, and appetite suppression.

Since ID110521156 is a small molecule compound, the Company's strategy is to develop it as an orally administrable drug for diabetes and obesity with differentiated attributes such as superior manufacturability and ease of use compared to peptide injections, the current standard of care.

A Yunovia representative emphasized, "ID110521156 is the only small molecule based new drug in the clinical stage among all GLP-1 receptor agonists in Korea, and even by the global market standards, it falls within the group of GLP-1 receptor agonists whose development status is relatively advanced."

The Company representative further stated, "We had been communicating with potential partner companies from the early development stage where their feedback from the perspective of the needs of the 'GLP-1 market', had been reflected in the designing of the SAD and MAD studies" Based on our continuing dialogue with them, we will proceed with further development of ID110521156 and, pursue global out-licensing.

About ID110521156

ID110521156 is an orally available small molecule agonist of the GLP-1 receptor. Yunovia completed its Phase I SAD, including food effect study, in July 2024. ID110521156 was well tolerated and demonstrated potential as a once-daily drug with a sustained PK profile. The company plans to collect PD data, including continuous glucose monitoring and body weight changes, as exploratory endpoints from a 4-week MAD study.

About Yunovia

Yunovia was established in 2023 as a split-off from Ildong pharmaceutical to release the full potential value of global, innovative drug pipeline and to maximize the R&D productivity for accelerated drug development. Yunovia's R&D pipeline includes more than 20 innovative programs at various development stages for various therapeutic areas. With its small molecule R&D expertise and pipeline, including 3+ clinical programs, Yunovia will strive to grow as a leading innovator for life changing therapeutics. For more information, please visit https://www.yunovia.com/eng/main/.

CONTACT: Hyang Choi, Business Development Team 2, Deputy General Manager, +82-2-526-3288, [email protected] 

SOURCE Yunovia