DanDi Bioscience

http://www.sentv.co.kr/news/view/599443  

This post has been translated from the original article dated 8/6/2021. 

[Seoul Economy TV=Reporter Bae Yo-han] Dandi Bioscience, a subsidiary of Next Science, entered into phase 1 clinical trials for sepsis and superbacteria treatment on the 6th with Eurofins Optimed, a global clinical contract organization (CRO) in France. He said he had signed a contract for a clinical trial.

'DD-S052', a peptide-based sepsis drug under development by Dandi Bioscience, not only directly kills super bacteria that cause sepsis, but also removes gram-negative bacteria-derived endotoxin, resulting in a cytokine storm. It is a new concept treatment with a dual mechanism of action that suppresses

Dandi Bioscience conducts preclinical safety tests with Spain's 'Anapath', a preclinical professional GLP (non-clinical testing standards certification body) certification testing agency, and at the same time, it has been conducting research on the development of unsolved infectious drugs, which is a national task of the Ministry of Health and Welfare since 2019. We have obtained a lot of data on pharmacokinetics, pharmacodynamics, and therapeutic efficacy while carrying out 'the task'. Based on the data obtained, it plans to prepare for a clinical trial with Eurofins Optimed this year and enter phase 1 clinical trials in France early next year.

Eurofins Optimed is a clinical contract organization (CRO) established by the French Eurofins group in 1987 and has a clinical drug production and analysis agency. The cumulative number of phase 1 clinical trials has reached 125, and many global pharmaceutical companies such as Novartis, Roche, and Sanofi are conducting clinical trials on consignment. Through this contract with Dandi Bioscience, it plans to act as an agent for the entire process, from comprehensive clinical trial consulting for ‘DD-S052’ to preparation of international common technical documents for pharmaceuticals, preparation of clinical trial applications, and clinical approval.

Dr. Eve, who is in charge of clinical regulation of Eurofins Optimed, said, "Based on the safety and therapeutic efficacy data of Dandi Bioscience, we will carefully prepare all the data for clinical trial application and make efforts to make it a successful clinical trial."

Park Young-min, CEO of Dandi Bioscience, said, "Based on Dandi Bioscience's excellent new drug development technology, Anapass's preclinical data, and collaboration with Eurofins Optimed, we plan to start clinical trials in Europe and other countries, starting with France, starting next year." In the future, before and after the phase 2 clinical trial of 'DD-S052', we will transfer the technology to multinational pharmaceutical companies and expand clinical trials on a global scale to make it a good option for sepsis treatment for which there is no suitable treatment alternative.”