MicrobiotiX Secures IND Approval for Korea’s First Human Trial of Bacteriophage Therapy MP101
MicrobiotiX Co., Ltd., has received Investigational New Drug (IND) approval from Korea’s Ministry of Food and Drug Safety (MFDS) for its investigational drug MP101, developed for the treatment of acute pneumonia.
The approval, granted on 21 October, allows MicrobiotiX to begin the first-in-human clinical trial of a bacteriophage-based therapeutic in Korea. The Phase 1 study is expected to enrol its first patient before the end of the year.
The clinical trial will be a randomised, double-blinded, placebo-controlled study evaluating the safety, tolerability, and pharmacokinetic and pharmacodynamic profile of MP101 in adults with Pseudomonas aeruginosa-induced pneumonia.
The company stated that this milestone represents a significant step in advancing Korea’s approach to infectious disease treatment—from reliance on antibiotics to precision bacteriophage therapies that directly target resistant bacteria.
MicrobiotiX has built an integrated R&D system combining clinical development and manufacturing capabilities to ensure effective therapeutic delivery.
With the launch of this first-in-human study, the company aims to demonstrate early proof of concept in severe respiratory infections and strengthen its global position through future collaborations in both domestic and international markets.
