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

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Seoul, South Korea, August 27, 2024 /PRNewswire/ — Unovia is Ildong Pharmaceutical GroupOn the 26th, Korea Ministry of Food and Drug Safety (MFDS) Following a successful Phase 1 single ascending dose (SAD) study, the company’s IND application has been approved for a Phase 1 multiple ascending dose (MAD) study of ID110521156, an orally administered small molecule GLP-1 agonist being developed for the treatment of obesity and diabetes.

A Phase 1 MAD study will be conducted to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) properties of ID110521156 following repeated dosing and dose escalation.

To date, Unovia has not only confirmed the efficacy of the drug as it relates to insulin secretion and glycemic control, but also confirmed that it is well tolerated compared to other drugs in its class through preclinical efficacy and toxicity evaluation in a 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, lowering blood sugar levels, regulating gastrointestinal motility, and suppressing appetite.

As ID110521156 is a small molecule compound, our strategy is to develop it into an orally administered diabetes and obesity treatment with differentiated properties such as: Excellent manufacturability It is also easier to use than peptide injections, the current standard of care.

A representative from Unovia emphasized that “ID110521156 is the only small molecule-based novel GLP-1 receptor agonist currently in clinical trials.” South Korea“It belongs to the group of GLP-1 receptor agonists that is relatively well developed by global market standards.”

The company’s representative further stated, “We have been in communication with potential partners since the early stages of development, and their feedback in terms of GLP-1 market needs has been reflected in the design of the SAD and MAD studies. Based on our ongoing dialogue with them, we will pursue further development of ID110521156 and pursue global out-licensing.”

About ID110521156

ID110521156 is an orally available small molecule agonist of the GLP-1 receptor. Unovia completed a Phase I SAD study, including food effects, in 2015. July 2024ID110521156 has demonstrated potential as a well-tolerated, once-daily agent with a durable PK profile, and the company plans to collect PD data, including continuous glucose monitoring and weight change, as exploratory endpoints from the four-week MAD study.

About Unobia

Yunovia was established in 2023 as a spinoff from Ildong Pharmaceutical to unlock the full potential value of its global innovative drug pipeline and maximize R&D productivity for accelerated drug development. Yunovia’s R&D pipeline contains over 20 innovative programs at various stages of development across multiple therapeutic areas. With its small molecule R&D expertise and pipeline, including more than three clinical programs, Yunovia aims to grow as a leading innovator of life-changing therapeutics. For more information, please visit https://www.yunovia.com/eng/main/.

contact: Choi HyangBusiness Development Team 2, Deputy General Manager, +82-2-526-3288, hyang.choi@ildong.com

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