MicrobiotiX Receives IND Approval for Novel Bacteriophage Drug MP101

Korea’s First Bacteriophage IND Approved by the Ministry of Food and Drug Safety – Phase 1 Trial to Begin in Patients with Acute Pneumonia

SEOUL, South Korea, Oct. 27, 2025 (GLOBE NEWSWIRE) — MicrobiotiX Co., Ltd. (CEO Dongeun Yong), a company specializing in the development of novel bacteriophage therapeutics, announced on October 27 that it received Investigational New Drug (IND) approval from the Ministry of Food and Drug Safety (MFDS) on October 21 for MP101, its investigational bacteriophage therapy for patients with acute pneumonia.

With this approval, MicrobiotiX becomes the first company in Korea to initiate a first-in-human (FIH) clinical trial for a bacteriophage-based therapeutic. The Phase 1 study is expected to enroll its first patient within the year.

“This IND approval marks a pivotal shift in Korea’s infectious disease drug development paradigm – from antibiotic dependence to precision bacteriophage-based therapies,” said Dongeun Yong, CEO of MicrobiotiX. “Through this first-in-human trial, a first in Korea, we aim to address the global public-health crisis of antimicrobial resistance (AMR), while strengthening the competitiveness and global standing of Korea’s bioindustry. MicrobiotiX will continue to grow as Korea’s leading innovator in novel anti-infective therapeutics.”

The Phase 1 trial is a randomized, double-blinded, placebo-controlled study designed to evaluate the safety, tolerability, and pharmacokinetic/pharmacodynamic (PK/PD) profile of MP101 in adult patients with Pseudomonas aeruginosa-induced pneumonia. The IND application was submitted to the MFDS in the second half of this year, and the clinical study will be conducted at leading clinical research institutions in Korea.

MicrobiotiX has established an execution-oriented R&D system that integrates clinical development with chemistry, manufacturing, and controls (CMC) capabilities – all aimed at delivering “phage therapies that work for patients when they need them.” With this first-in-human entry, the company plans to demonstrate early proof-of-concept (PoC) in high-unmet-need indications such as severe respiratory infections and accelerate its global clinical and commercialization strategies through partnerships in Korea and abroad.

About MP101
MP101 is a bacteriophage cocktail composed of two active lytic phages, MXP1001 and MXP1002, which specifically target and eliminate the bacteria Pseudomonas aeruginosa. The cocktail formulation broadens the therapeutic coverage against clinically relevant P. aeruginosa strains. Genomic analysis confirmed that both phages lack lysogenic, antibiotic resistance, and toxin-related genes. Non-clinical studies demonstrated synergistic antibacterial effects and no significant toxicity when MP101 was co-administered with various antibiotics.

CONTACT: Contact information: BD@microbiotix.net