Bagel Labs Co., Ltd. applies for IND approval from the Ministry of Food and Drug Safety for sarcopenia DTx 'DEX-2'

[Financial News] Bagel Labs Co., Ltd. has applied to the Ministry of Food and Drug Safety for approval of the Investigational New Drug (IND) application for 'DEX-2,' a digital therapeutic device (DTx) for sarcopenia. Following the confirmation of improvement trends in key muscle function indicators through preliminary studies, the company is entering the formal clinical phase to verify safety and efficacy in actual patients.
Bagel Labs Co., Ltd. announced on the 2nd that it had completed the application for approval of the clinical trial plan for DEX-2. The company, which has been developing a research prototype and conducting preliminary research with sarcopenia as its first indication, plans to proceed in earnest with clinical trials and regulatory approval procedures following this application.
Upon receiving approval for the clinical trial plan from the Ministry of Food and Drug Safety, the company plans to conduct a formal clinical trial and use the clinical results obtained in the future as the basis for product approval.
Bagel Labs Co., Ltd. developed the DEX-2 research prototype with support from the Ministry of Trade, Industry and Energy (MOTIE)'s Bio-industry Technology Development Project. Subsequently, it conducted preliminary research with the research team of Professor Kwang-il Kim of the Department of Geriatric Medicine and Professors Lim Jae-young and Beom Jae-won of the Department of Rehabilitation Medicine at Seoul National University Bundang Hospital.
The preliminary study showed improvement trends in key assessment indicators for sarcopenia, including the Short Physical Performance Battery (SPPB), walking speed, and the phase angle measured by bioelectrical impedance analysis (BIA), among participants who received the DEX-2 exercise intervention.
Based on these findings, the company specified the exercise intervention protocol and clinical evaluation indicators and reflected them in the clinical trial plan.
DEX-2 is a digital rehabilitation platform that uses AI-based image recognition technology to analyze users' joint movements and exercise postures in real time. Without separate sensors or exercise equipment, it provides feedback on the number and accuracy of repetitions using only a smartphone camera and adjusts the exercise difficulty according to users' physical function and exercise performance.
The goal is to enable patients with sarcopenia to continue rehabilitation exercises at home, tailored to their physical abilities, without visiting hospitals or specialized facilities.
Bagel Labs Co., Ltd. is expanding its business beyond sarcopenia to obesity and muscle management. A representative example is 'DEX-1-OB,' a digital convergence drug for obesity being jointly developed with Hanmi Pharmaceutical. DEX-1-OB aims to combine Hanmi Pharmaceutical's GLP-1-class obesity drug 'efpeglenatide' with a digital therapeutic device, linking drug treatment with lifestyle management, including diet and exercise, in a single treatment system.
The company is also conducting a pilot study comparing the combined use of GLP-1-class obesity treatments and digital therapeutic devices with drug administration alone. It plans to establish a strategy for addressing muscle loss in conjunction with GLP-1-class treatments by analyzing not only weight loss but also how much muscle mass is preserved and physical function is maintained during the weight-loss process.
Bagel Labs Co., Ltd. CEO Park Soo-hong said, "This application signifies that DEX-2 has completed its preliminary research and entered the formal clinical verification stage for product approval," adding, "Through clinical trials, we will objectively verify its potential to improve physical function and muscle quality and demonstrate the product's competitiveness."
Meanwhile, Xperix acquired Bagel Labs Co., Ltd., a company specializing in the commercialization of digital convergence drugs, in September last year to enter the new healthcare business.

[email protected] Kang Jung-mo Reporter