MicrobiotiX has completed the sentinel cohort of its Phase I, first-in-human clinical trial evaluating MP101 in adult patients with pneumonia caused by Pseudomonas aeruginosa.
Following a 72-hour tolerability and safety assessment, no safety concerns were identified among the initial participants that would prevent the trial from continuing.
On this basis, enrolment of the remaining participants in the first cohort is proceeding as planned.
The double-blind, placebo-controlled and randomised trial aims to enrol 18 adults with acute P. aeruginosa pneumonia.
Participants are receiving a single intravenous dose of either MP101 or placebo alongside standard antibiotic therapy in sequential dose groups.
The primary objectives are to evaluate the safety and tolerability of MP101, while also gathering data on its pharmacokinetic and pharmacodynamic properties and exploring its antibacterial activity and clinical outcomes.
Enrolment is ongoing at multiple clinical sites in South Korea, and MicrobiotiX plans to open additional locations in response to investigator interest. This will broaden participation and help accelerate recruitment as the programme progresses.
This study is said to be the first clinical trial of a bacteriophage-based therapeutic to be approved by South Korea's Ministry of Food and Drug Safety.
MicrobiotiX stated that experience gained in this trial will inform the future development of MP101 and help establish a clinical development model for bacteriophage therapeutics in South Korea and abroad.
Pseudomonas aeruginosa is described as a significant cause of hospital-acquired and ventilator-associated pneumonia, with high rates of multidrug resistance presenting ongoing challenges.
A recent analysis in the Lancet identified lower respiratory infections as leading contributors to deaths related to bacterial antimicrobial resistance worldwide.
MicrobiotiX CEO Dr Dongeun Yong said: "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.
"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 trial programme for MP101 is supported by the Korean Ministry of Health and Welfare through its Infectious Disease Prevention and Treatment Technology Development Project, which aims to advance the clinical and regulatory development of bacteriophage therapies.
"MicrobiotiX concludes sentinel cohort in Phase I trial of MP101" was originally created and published by Clinical Trials Arena, a GlobalData owned brand.