Approval of IND for phase I clinical trial for Endolysin LNT103

April 02, 2024

  LyseNTech (CEO Myung Heejoon) announced that it has received approval from the Ministry of Food and Drug Safety for a phase 1 clinical trial (IND) for LNT103, an endolysin antibiotic targeting Gram-negative bacteria. There have been three cases of endolysin targeting Gram-positive bacteria entering clinical trials at home and abroad, but LyseNTech is said to be the world's first endolysin targeting Gram-negative bacteria, which is technically much more difficult, to enter clinical trials. In the future, safety and pharmacokinetic properties will be evaluated on 64 healthy adults at Seoul National University Hospital.

  Rapidly increasing antibiotic resistance is a serious problem worldwide. According to a 2014 UK government report, the number of deaths due to antibiotic resistance is expected to reach 10 million worldwide by 2050, surpassing the number of deaths due to cancer. However, a paper reported in Lancet in 2022 found that the number of deaths related to antibiotic resistance had already reached 4.95 million in 2019, increasing much faster than predicted in 2014. However, as big pharma's antibiotic development pipeline is depleted, the possibility of the next pandemic caused by resistant bacteria is increasing.

  Lysentech's Endolysin is a recombinant protein drug made by engineering an enzyme derived from bacteriophage, and preclinical trials have been completed with support from the Ministry of Science and ICT's Innovative New Drug Pipeline Development Project since 2019. Patents have been secured in Korea, the United States, and China, and the process of securing patents is currently underway in other major countries.

  Director Kim Min Soo of Lycentech explained, “Due to the characteristics of endolysin, which is different from existing antibiotics in its target and mode of action, and not allowing development of resistance, it will provide a groundbreaking turning point in the treatment of antibiotic-resistant Gram-negative bacterial infections in the future.”