Photo Caption: Dr. Dongeun Yong, CEO, gives a tour of MicrobiotiX’s GMP facility, where the clinical material being used in the MP101 trial was manufactured.
SEOUL, South Korea, Aug. 26, 2026 (GLOBE NEWSWIRE) — MicrobiotiX Co., Ltd., a clinical-stage biotechnology company developing bacteriophage-based therapeutics for difficult-to-treat bacterial infections, today announced the successful completion of the sentinel cohort of its first-in-human Phase 1 clinical trial evaluating MP101 in patients with pneumonia caused by Pseudomonas aeruginosa.
Following completion of the initial 72-hour safety and tolerability assessment of the sentinel participants, no safety concerns were identified that prevented trial continuation. Accordingly, enrollment of the remaining participants in Cohort 1 is proceeding as planned.
The randomized, double-blind, placebo-controlled Phase 1 study is designed to enroll 18 adult patients with acute P. aeruginosa pneumonia. Participants receive a single intravenous administration of MP101 or placebo in addition to standard-of-care antibiotic therapy across sequential dose cohorts. The study is designed primarily to evaluate the safety and tolerability of MP101 while also characterizing its pharmacokinetic and pharmacodynamic profile and exploring measures of antibacterial activity and clinical outcomes.
Patient enrollment is ongoing across multiple clinical trial sites in South Korea. MicrobiotiX also plans to activate additional study sites in response to investigator interest, supporting broader clinical participation and accelerating patient recruitment as the program advances.
The MP101 study is the first Ministry of Food and Drug Safety (MFDS)-approved clinical trial of a bacteriophage-based therapeutic in South Korea. As the program advances beyond its initial sentinel stage, MicrobiotiX is building clinical experience that will help inform the future development of MP101 and contribute to establishing a clinical development framework for bacteriophage therapeutics in Korea and internationally.
The targeted pathogen of Pseudomonas aeruginosa is a major cause of hospital-acquired and ventilator-associated pneumonia and is frequently associated with multidrug resistance, leaving critically ill patients with increasingly limited treatment options. The challenge forms part of a much broader global burden: a landmark analysis published in The Lancet identified lower respiratory infections as the infectious syndrome associated with the greatest number of deaths linked to bacterial antimicrobial resistance globally.
By evaluating MP101 directly in patients with acute P. aeruginosa pneumonia, MicrobiotiX aims to generate evidence not only to guide the continued development of MP101, but also to help establish the clinical potential of bacteriophage-based therapeutics against high-priority bacterial infections.
“Advancing MP101 beyond the initial sentinel stage brings us another step closer to determining how bacteriophage therapeutics can be developed for patients facing serious infections with increasingly limited treatment options,” said Dr. Dongeun Yong, Chief Executive Officer of MicrobiotiX. “Antimicrobial resistance remains one of the most urgent challenges in infectious disease, and we believe rigorous clinical development will be essential to translating the unique potential of phage therapy into practical treatment options for patients.”
The clinical development of MP101 is being supported by the Korean Ministry of Health and Welfare through its Infectious Disease Prevention and Treatment Technology Development Project. This support is helping MicrobiotiX advance MP101 through clinical evaluation and regulatory development, while also supporting research aimed at improving the clinical utility and practical implementation of bacteriophage therapeutics. These efforts contribute to broader national initiatives to develop innovative approaches to antimicrobial-resistant infections. MicrobiotiX gratefully acknowledges the continued support of the Korean government and its commitment to advancing domestic innovation in infectious-disease therapeutics.
Beyond MP101, the clinical experience generated through the study is expected to inform MicrobiotiX’s broader bacteriophage therapeutic pipeline. The company is applying its phage discovery, manufacturing and clinical development capabilities to additional programs targeting serious respiratory infections caused by pathogens including Klebsiella pneumoniae and non-tuberculous mycobacteria.
MicrobiotiX’s longer-term strategy is to establish a repeatable clinical development pathway for bacteriophage therapeutics: demonstrating safety and biological activity in early clinical studies, expanding promising programs through strategic collaborations, and advancing candidates into proof-of-efficacy trials. Through this approach, the company aims to accelerate the development of scalable, evidence-based phage medicines for patients with limited treatment options.
About MicrobiotiX
MicrobiotiX is a clinical-stage biotechnology company developing bacteriophage-based therapeutics for antibiotic-resistant and difficult-to-treat bacterial infections, with an initial focus on respiratory diseases. The Company is advancing a pipeline of phage cocktail therapeutics targeting high-priority bacterial pathogens, including Pseudomonas aeruginosa, Klebsiella pneumoniae, and non-tuberculosis mycobacterium associated with serious acute and chronic respiratory infections.
Its lead program, MP101, is being evaluated in Korea’s first MFDS-approved first-in-human clinical trial of a bacteriophage-based therapeutic and is being developed for the treatment of acute P. aeruginosa pneumonia.
MicrobiotiX combines a proprietary bacteriophage library with integrated drug development capabilities, including phage characterization, PK/PD modeling, and evaluation of phage-antibiotic synergy, to support the translation of bacteriophage candidates from discovery through clinical development. The Company also operates an in-house GMP-grade phage manufacturing facility, providing control over drug substance and drug product manufacturing to support its current and future clinical programs.
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/a33fc06c-d16c-40d0-b15d-91a8fae6b744
Contact: bd@microbiotix.net
