Daewon Pharmaceutical (003220.KS) will present research findings in the United States on DW5324, an oral semaglutide candidate built on its own drug delivery platform. After confirming higher drug exposure than an existing product in a human pharmacokinetic study, the company plans to optimize the formulation and seek clinical entry in South Korea next year.
Daewon Pharmaceutical said on the 23rd that it will present two sets of preclinical and human pharmacokinetic results for DW5324 at AAPS PharmSci 360, the annual meeting of the American Association of Pharmaceutical Scientists, held in New Orleans from the 25th to the 28th. Semaglutide is used to treat diabetes and obesity.
DW5324 is a drug candidate that applies Daewon Pharmaceutical's proprietary oral drug delivery platform, which uses a polymer and lipid complex. The platform is designed to protect peptide drugs from breaking down in the digestive tract and to control the timing of release, while improving absorption through the gastrointestinal mucosa.
In a crossover human pharmacokinetic study, the formulation using the proprietary platform showed drug exposure, measured by area under the curve, of 1.90 to 3.14 times that of Novo Nordisk's oral semaglutide Rybelsus at 14 milligrams, the standard treatment. AUC is a measure that aggregates drug concentration in the blood over a set period. Maximum blood concentration, or Cmax, was up to 2.90 times higher. An official at Daewon Pharmaceutical said the company expects to avoid patent barriers by applying its own formulation design without using SNAC, the absorption enhancer used in existing products.
After the conference presentations, the company plans to optimize the formulation and file an investigational new drug application for a Phase 1 trial in South Korea in 2027. It also intends to pursue platform licensing talks with global pharmaceutical companies based on the data it has accumulated.
Kim Joo-il, head of research and development at Daewon Pharmaceutical, said the company will further optimize the formulation to meet global standards and bring product development and overseas licensing into view without setbacks, adding that it will broaden the platform's application to a range of biologic drugs.