Ildong Pharmaceutical Group held an investor relations (IR) meeting on the 29th and disclosed the topline data from Phase 1 clinical trials related to the obesity and diabetes treatment candidate 'ID110521156'.

The new drug candidate ID110521156 is a glucagon-like peptide-1 receptor agonist (GLP-1) class drug. Like Wegovy and Zepbound, it is being developed as a treatment that utilizes the similar role of the GLP-1 hormone, which is involved in insulin synthesis and secretion, blood sugar reduction, gastrointestinal motility regulation, and appetite suppression. However, Ildong Pharmaceutical aims to develop it as an oral administration treatment.

The Phase 1 clinical trial was designed with a focus on evaluating safety, tolerability, and pharmacological characteristics. The study was conducted using methods such as random assignment, double-blind, and placebo control. The research was carried out in two stages: a single ascending dose (SAD) study and a multiple ascending dose (MAD) study.

According to Ildong Pharmaceutical, the SAD study showed results where drug exposure was maintained at a level exceeding the effective concentration in the blood for more than 18 hours (up to 24 hours). It was reported that no drug accumulation occurred with repeated administration, and it was not affected by diet, confirming pharmacokinetic characteristics suitable for once-daily oral administration.

In the MAD study, pharmacodynamic efficacy such as weight loss and blood sugar reduction was also confirmed. The MAD study was conducted with 36 healthy adults hospitalized in clinical institutions. The dosage was divided into three groups: 50mg, 100mg, and 200mg. The clinical trial was conducted by administering the drug once daily for four weeks, with 12 subjects assigned per cohort. As a result, the 50mg and 100mg groups showed an average weight loss of 5.5% and 6.9%, respectively, over four weeks. The 200mg group showed an average weight loss of 9.9%, with a maximum of 13.8%. The results confirmed dose-dependent drug efficacy with a proportional relationship between dosage and weight loss.

In the placebo group, the proportion of subjects showing more than 5% weight loss after four weeks of administration was recorded at 0%. In contrast, the proportions of subjects with more than 5% weight loss in the 50mg and 100mg groups were 55.6% and 66.7%, respectively. The 200mg group showed a proportion of 87.5%, securing clinically significant data. Additionally, Ildong Pharmaceutical explained that dose-dependent blood sugar lowering efficacy was confirmed through oral glucose tolerance tests (OGTT) and continuous glucose monitoring (CGM), which can observe changes in blood sugar levels.

Safety results were also confirmed. Although there was no dose adjustment process for drug adaptation, gastrointestinal side effects were observed at a mild level without any serious adverse events in all cohorts. There were no clinical discontinuations or dropouts due to the drug. Furthermore, even with repeated administration, liver enzyme levels remained within the normal range, and there were no cases of drug-induced liver injury concerns.

Lee Jae-jun, Chief Operating Officer (COO) of Ildong Pharmaceutical and CEO of Yunovia, stated, "Through this clinical study, we confirmed the excellent weight loss efficacy and safety profile of the candidate substance," adding, "It has shown the potential to be a 'best-in-class' new drug in the field of obesity and diabetes."

He continued, "As an oral synthetic new drug candidate based on small molecule compounds, it has distinct differentiators in terms of pharmacological characteristics, manufacturing efficiency and economy, ease of use, and commercialization prospects compared to existing peptide injectables," emphasizing, "Although it is an oral formulation, it is characterized by good absorption and maintenance of blood concentration, with excellent efficacy, and the production cost is significantly lower, making it very advantageous in the commercialization process."

Ildong Pharmaceutical Group plans to accelerate follow-up research and development with the goal of entering global Phase 2 clinical trials next year. It also reported that it is concurrently engaging in commercialization-related partnering activities such as global licensing out.

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