Sangsun Yoon, CEO of BioMe
Currently developing BM111, an antibiotic-resistant bacterial infection treatment, in collaboration with Celltrion
Aiming to present a new paradigm encompassing not only patient treatment but also disease prevention
“BioMe currently has a product pipeline targeting various conditions, including rare diseases, cardiovascular diseases, and antibiotic-resistant infections. We are actively conducting research and development with the goal of entering clinical trials. Furthermore, through collaboration with a network of over 35 medical clinics and hospitals nationwide, we have accumulated clinical experience in fecal microbiota transplantation (FMT). Based on this experience, we are developing a precise and safe platform for therapeutic microorganisms. BioMe aims to provide innovative, patient-centered therapeutic solutions through microbiome therapeutics and to become a global market leader.”
Biomi is currently conducting R&D centered around three main pipelines. The first, BM111, is an antibiotic-resistant bacterial infection treatment developed jointly with Celltrion. This treatment targets multidrug-resistant bacteria, such as VRE and CPE, that are resistant to existing antibiotics. BM111 recently received approval from the Severance Hospital Institutional Review Board (IRB) and is scheduled to begin clinical trials this year. BM111 is anticipated to offer a new alternative to traditional antibiotic treatments.
The second pipeline, BM109, is a microbiome therapeutic that breaks down trimethylamine (TMA), a harmful metabolic byproduct produced in the human gut. BM109 was selected for the non-clinical track of the Korea Drug Development Fund (KDDF), and an Investigational New Drug (IND) application will be submitted to the U.S. Food and Drug Administration (FDA). In May of this year, BM109 received orphan drug designation (ODD) from the FDA as a treatment for trimethylamineuria (TMAU), a rare disease. After initiating clinical trials with TMAU patients, the company plans to expand its use to include the treatment of cardiovascular disease. To this end, BM109 was selected for the Scale-up TIPS project this summer.
The third, BM107 is a product in development as a healthy functional food. It is based on enhancing butyrate, a key gut metabolite. BM107 is being developed as a multi-target health functional food that offers cognitive improvement, anti-obesity, and anti-inflammatory effects simultaneously.
BioMe aims to present a new paradigm that encompasses not only patient treatment but also disease prevention through innovative microbiome therapeutics and functional materials.
BioMe’s greatest competitive advantage lies in its screening technology, which is based on the mode of action (MoA) of fecal-derived microorganisms. BioMe’s approach goes beyond merely observing the functions that specific microorganisms perform in the human body. First, it targets metabolites directly linked to therapeutic effects (e.g., TMA and butyrate) and then screens microorganisms that can decompose or produce them.
Above all, BioMe is focusing its efforts on entering the global market. First, BM109 plans to conduct clinical trials in the U.S. following FDA Investigational New Drug (IND) approval. After initiating clinical trials for the rare disease TMAU, the plan is to expand the indication to cardiovascular disease. To this end, BioMe founded a local subsidiary named SomaCure Therapeutics in Maryland this summer. This lays the groundwork for local clinical development and commercialization.
Regarding future plans, Yoon stated, “BioMe’s top priority in the short term is to ensure the smooth progression of our currently ongoing BM111 and BM109 pipeline into clinical trials.” He added, “BM111, an antibiotic-resistant infection treatment, is scheduled to begin clinical trials in Korea. For BM109, after having received FDA IND approval, it will initiate clinical trials in the U.S. as a rare disease treatment, with plans to subsequently expand its indications to cardiovascular diseases.”
Founded: November 2020
Main business: development of live microbial biotherapeutic products (LBPs), fecal microbiota transplantation (FMT), and development of health functional foods
Achievements: Successfully attracted Series A investment in June 2025; Selected for the KDDF non-clinical track (BM109); Signed a joint development partnership for an open innovation program with Celltrion (BM111); Selected for the Scale-up TIPS project for expanding the cardiovascular disease indication of BM109; Executed multiple government support projects, including the Startup Scale-up Package; Received ODD for BM109 from the U.S. FDA in May 2025; Accumulated clinical experience in FMT through a network of 35 medical clinics and hospitals nationwide; Founded U.S. subsidiary SomaCure Therapeutics in Maryland; Laid the groundwork for global clinical trials and commercialization; Initiated discussions with a Thai partner about transferring ASEAN rights for BM107
reporter jinho lee
jinho2323@hankyung.com
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