Korea’s Ministry of Food and Drug Safety Approves First Bacteriophage IND – Phase 1 Trial for Acute Pneumonia Patients Set to Begin
SEOUL, South Korea, Oct. 27, 2025 — MicrobiotiX Co., Ltd., a company focused on developing novel bacteriophage therapeutics, announced on October 27 that it had received Investigational New Drug (IND) approval from the Ministry of Food and Drug Safety (MFDS) on October 21. This approval is for MP101, its investigational bacteriophage therapy intended for patients suffering from acute pneumonia.
This milestone positions MicrobiotiX as the first company in Korea to commence a first-in-human (FIH) clinical trial for a bacteriophage-based treatment. Enrollment for the Phase 1 study is anticipated to begin with its initial patient within the current year.
“This IND approval signifies a crucial shift in Korea’s infectious disease drug development approach, moving from antibiotic reliance to precise bacteriophage-based therapies,” stated Dongeun Yong, CEO of MicrobiotiX. “Through this inaugural first-in-human trial in Korea, we aim to tackle the global public health challenge of antimicrobial resistance (AMR), while simultaneously bolstering the competitiveness and international standing of Korea’s bioindustry. MicrobiotiX is committed to advancing as Korea’s leading innovator in new anti-infective therapeutics.”
The Phase 1 trial will be a randomized, double-blinded, placebo-controlled study. Its primary objective is to assess the safety, tolerability, and pharmacokinetic/pharmacodynamic (PK/PD) profile of MP101 in adult patients diagnosed with Pseudomonas aeruginosa-induced pneumonia. The IND application was submitted to the MFDS in the latter half of this year, and the clinical study will be conducted at prominent clinical research institutions across Korea.
MicrobiotiX operates an execution-driven R&D framework that integrates clinical development with robust chemistry, manufacturing, and controls (CMC) capabilities, all focused on delivering “phage therapies that work for patients when they need them.” With this entry into first-in-human trials, the company intends to swiftly demonstrate early proof-of-concept (PoC) in areas of high unmet medical need, such as severe respiratory infections, and to accelerate its global clinical and commercialization strategies through both domestic and international partnerships.
About MP101
MP101 is a bacteriophage cocktail comprising two active lytic phages, MXP1001 and MXP1002. These phages are designed to specifically target and eliminate the bacterium Pseudomonas aeruginosa. The cocktail formulation enhances therapeutic coverage against a broad spectrum of clinically relevant P. aeruginosa strains. Genomic analysis has confirmed the absence of lysogenic, antibiotic resistance, and toxin-related genes in both phages. Non-clinical studies have also shown synergistic antibacterial effects and no significant toxicity when MP101 was co-administered with various antibiotics.
CONTACT: Contact information: BD@microbiotix.net
