N-Rephasin® SAL200 IRB(Institutional Review Board) Approval
03 January,2017

N-Rephasin® SAL200 IRB (Institutional Review Board) Approval


iNtRON Biotechnology, Inc(CEO Kyungwon Yoon) said on Jan 4 that they received the IRB approval from Seoul National University Hospital for Phase II Clinical trial on human of N-Rephasin® SAL200, the bio-drug targeting Superbacteria.


This approval is about N-Rephasin®


SAL200 which is being developed as MRSA treatment drug and its multi-institutional Phase II clinical trial plan on human subject. Through the Phase II clinical trial, safety and efficacy of N-Rephasin® SAL200 will be investigated.


 ‘N-Rephasin® SAL200‘ is based on Endolysin, a novel antibactericidal protein originated from bacteriophages and it offers extraordinary efficacy in treating infections caused by both antibiotic resistant bacteria and antibiotic tolerant bacteria. N-Rephasin® SAL200 is totally different from conventional antibiotics in targeting method and mode of action, and these differences confer N-Rephasin® SAL200 the unique feature. And these characteristics prove N-Rephasin® SAL200 to be a first-in-class bio-drug. Throughout the antibiotic development history, there has been astronomical amounts of investments, however only three innovations that were approved as novel.


The clinical trial of N-Rephasin® SAL200 is the first human subject efficacy clinical trial of novel Endolysin protein drug. iNtRON Biotechnology has put a lot of effort and time on This clinical trial preparation and sought expert consultations from global clinical research operators.


Soo youn Jun, the senior Technical Director of iNtRON Biotechnology institute, said “Since this trial drug is a totally new bio-drug, we applied various most up-to-date analysis methods to procure  multifaceted information”. And she added “this clinical trial will be performed in two different hospitals- Seoul National University main Hospital and its Branch Hospital in Bundang”


Kyungwon Yoon, the CEO, said “The IRB approval is meaningful in the progression of the N-Rephasin® SAL200’s clinical trial and is also helpful for the ongoing Technology licensing-out negotiations.



it is iNtRON.