MicrobiotiX announced on the 23rd that it received approval from the Ministry of Food and Drug Safety (MFDS) on October 21 for its Phase 1 clinical trial application (IND) of the bacteriophage-based candidate MP101 for acute pneumonia.
With this approval, MicrobiotiX becomes the first domestic biotech company to enter “first-in-human” clinical trials for a bacteriophage therapeutic. The company plans to begin the first patient enrollment within this year.
MP101 is a cocktail of two active bacteriophages, MXP1001 and MXP1002. Both phages are lytic, capable of infecting and destroying Pseudomonas aeruginosa. The use of this cocktail is expected to maximize the range of P. aeruginosa strains that can be targeted. In preclinical studies, MicrobiotiX confirmed that each phage is non-lysogenic and free from antibiotic resistance and toxic genes. The phages showed synergistic effects when co-administered with various antibiotics and exhibited no significant toxicity.
Yong-Dong Yoon, CEO of MicrobiotiX, stated, “With this IND approval, we hope to mark a turning point in infectious disease treatment by shifting from conventional antibiotic-dependent approaches to bacteriophage-based precision therapies. Through this first domestic clinical entry, we aim to make a real impact against the global public health threat of antimicrobial resistance (AMR) while strengthening the competitiveness and global standing of Korea’s bioindustry. MicrobiotiX will continue to grow as a leading company in innovative infectious disease therapeutics.”
The Phase 1 clinical trial is a randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of MP101 in adult patients with acute Pseudomonas aeruginosa pneumonia in Korea. The IND was submitted to the MFDS in the second half of this year.
A company representative added, “We aim to develop phage therapeutics that work precisely and promptly at the patient’s bedside. To this end, we have built an implementation-oriented R&D system that integrates clinical development with manufacturing and quality (CMC) capabilities. With the launch of this clinical trial, we plan to demonstrate treatment potential early in high unmet-need indications such as severe respiratory infections and to accelerate global clinical and commercialization strategies through domestic and international partnerships.”
Reporter: Sungmin Kim (sungmin.kim@bios.co.kr)
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Press releases and tips: press@bios.co.kr
[source] 마이크로바이오틱스, '박테리오파지 신약' 국내 1상 승인 - 바이오스펙테이터
With this approval, MicrobiotiX becomes the first domestic biotech company to enter “first-in-human” clinical trials for a bacteriophage therapeutic. The company plans to begin the first patient enrollment within this year.
MP101 is a cocktail of two active bacteriophages, MXP1001 and MXP1002. Both phages are lytic, capable of infecting and destroying Pseudomonas aeruginosa. The use of this cocktail is expected to maximize the range of P. aeruginosa strains that can be targeted. In preclinical studies, MicrobiotiX confirmed that each phage is non-lysogenic and free from antibiotic resistance and toxic genes. The phages showed synergistic effects when co-administered with various antibiotics and exhibited no significant toxicity.
Yong-Dong Yoon, CEO of MicrobiotiX, stated, “With this IND approval, we hope to mark a turning point in infectious disease treatment by shifting from conventional antibiotic-dependent approaches to bacteriophage-based precision therapies. Through this first domestic clinical entry, we aim to make a real impact against the global public health threat of antimicrobial resistance (AMR) while strengthening the competitiveness and global standing of Korea’s bioindustry. MicrobiotiX will continue to grow as a leading company in innovative infectious disease therapeutics.”
The Phase 1 clinical trial is a randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of MP101 in adult patients with acute Pseudomonas aeruginosa pneumonia in Korea. The IND was submitted to the MFDS in the second half of this year.
A company representative added, “We aim to develop phage therapeutics that work precisely and promptly at the patient’s bedside. To this end, we have built an implementation-oriented R&D system that integrates clinical development with manufacturing and quality (CMC) capabilities. With the launch of this clinical trial, we plan to demonstrate treatment potential early in high unmet-need indications such as severe respiratory infections and to accelerate global clinical and commercialization strategies through domestic and international partnerships.”
Reporter: Sungmin Kim (sungmin.kim@bios.co.kr)
© BioSpectator. Unauthorized reproduction, redistribution, or AI-training use prohibited.
Press releases and tips: press@bios.co.kr
[source] 마이크로바이오틱스, '박테리오파지 신약' 국내 1상 승인 - 바이오스펙테이터