Yunovia has announced the approval of its investigational new drug (IND) application by the Ministry of Food and Drug Safety (MFDS) of South Korea, enabling a future Phase I study of its small molecule glucagon-like peptide-1 (GLP-1) agonist, ID110521156.
This IND clearance for the multiple-ascending dose (MAD) trial follows the successful completion of a Phase I single-ascending dose (SAD) study.
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The upcoming Phase I MAD study will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) characteristics of ID110521156 for treating obesity and diabetes.
It will involve repeated administration and a stepwise increase in dosage over four weeks.
Yunovia aims to gather PD data, including continuous glucose monitoring and body weight changes, as exploratory endpoints.
The company previously reported that ID110521156 enhanced insulin secretion and blood glucose control.
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By GlobalDataThe drug is also claimed to have exhibited superior tolerability when compared to other drugs in the same class during preclinical efficacy and toxicity evaluations in the recently completed Phase I SAD study.
ID110521156 is said to mimic the GLP-1 hormone’s role in insulin synthesis and secretion, blood glucose level reduction, gastrointestinal tract movement regulation, and appetite suppression.
Yunovia’s strategy is to develop ID110521156 as an orally administrable drug, with advantages such as superior manufacturability and ease of use over peptide injections, which are the current standard of care.
Last month, Yunovia completed its Phase I SAD study, including a food effect study.
The drug was found to be well tolerated and showed potential as a once-daily medication, with a sustained PK profile.
In a media release, Yunovia representative said: “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.”
“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.”
