MicrobiotiX Receives IND Approval for Novel Bacteriophage Therapy MP101
Tuesday, October 28, 2025
MicrobiotiX Co., Ltd., a biotechnology company focused on developing innovative bacteriophage-based therapeutics, has received Investigational New Drug (IND) approval from the Ministry of Food and Drug Safety (MFDS) for its investigational therapy MP101, designed to treat acute pneumonia. The approval was granted on 21 October.
This milestone makes MicrobiotiX the first company in Korea to begin a first-in-human clinical trial for a bacteriophage therapeutic. The Phase 1 trial is expected to enrol its first participant before the end of the year.
The study will be a randomised, double-blinded, placebo-controlled trial evaluating the safety, tolerability, and pharmacokinetic/pharmacodynamic (PK/PD) profile of MP101 in adult patients with pneumonia caused by Pseudomonas aeruginosa. The trial will be carried out at major clinical research institutions across Korea.
MicrobiotiX has developed an integrated R&D framework combining clinical development with chemistry, manufacturing, and controls (CMC) functions to support the advancement of phage-based medicines. With this first-in-human trial, the company aims to demonstrate early proof-of-concept in high-unmet-need areas such as severe respiratory infections.
The company also plans to strengthen its global presence by pursuing strategic partnerships both in Korea and internationally, contributing to efforts to tackle antimicrobial resistance (AMR) and advance next-generation anti-infective therapies.
Source: globenewswire.com
