LyseNTech filed IND for phase 1 clinical trial of its endolysin
LyseNTech / 2023-11-23
November 23, 2023
Lysentech (CEO Heejoon Myung), a company specializing in bacteriophages, announced that it has submitted a phase 1 clinical trial protocol (IND) for ‘LNT103’, an endolysin antibiotic targeting Gram-negative bacteria, to the Ministry of Food and Drug Safety of Korea.
The clinical trial for which Lysentech has applied this time is going to be conducted at Seoul National University Hospital to evaluate the safety, tolerability, and pharmacokinetics of LNT103 endolysin in healthy volunteeres.
The spread of antibiotic-resistant bacteria is becoming a major social and health problem around the world, and warning messages are being sent from the World Health Organization (WHO), the U.S. Centers for Disease Control and Prevention (CDC), and the Ministry of Food and Drug Safety. Many studies are being conducted to control antibiotic-resistant bacteria, and experts predict that endolysin, an antibacterial protein derived from bacteriophages, will be a solution. The LNT103 endolysin antibiotic being developed by Lysentech is the world's first endolysin-based antibiotic targeting Gram-negative bacteria, completing non-clinical development and entering clinical trials.
Dr. Kim Min-soo (CSO) said, “We have confirmed through in vitro and animal tests that LNT103 endolysin has excellent antibacterial efficacies against Gram-negative bacteria, and toxicity tests on animals have also been completed. It is expected to become a new antibiotic against multidrug-resistant Gram-negative bacteria. In addition, we have secured patent rights in Korea, the United States, and China, and are under review in other major countries. We will do our best to quickly complete clinical trials and transfer the technology to global pharmaceutical companies.”