DanDi Bioscience

https://pharm.edaily.co.kr/news/read?newsId=02994646632398784&mediaCodeNo=257  

This post has been translated from the original article dated 7/27/2022. 

[Reporter Na Eun-kyung of E-Daily] HLB Science, a peptide-based new drug development company, announced on the 27th that it has been approved by the French Ministry of Food and Drug Safety (ANSM) for phase 1 clinical trial plan (IND) for developing new drugs for sepsis and gram-negative superbacterial infections. It was approved for clinical initiation about a month after applying for phase 1 IND of DD-S052P to ANSM on June 13. The company believes that despite the high mortality rate, the authorities' expectations for the development of sepsis treatments that do not yet have suitable diagnostic methods or treatment alternatives are reflected. Phase 1 clinical trials will be conducted on 72 healthy subjects at "Eurofiins Optimized" in France. In this clinical trial, HLB Science plans to check the safety, drug resistance, and blood drug dynamics of the next-generation sepsis treatment "DD-S052P," which neutralizes bacterial killing as well as endotoxins. Sepsis is pointed out as a major cause of cytokine storms (immune hypersensitivity reactions) in which immune cells excessively secrete immune substances in response to endotoxins caused by bacteria and viruses. If the causative bacteria cannot be removed within a short time, a systemic inflammatory reaction occurs and major organs are damaged. Worldwide, 50 million sepsis patients occur every year, and about 11 million die. However, so far, there are no suitable treatments other than antibiotic prexxxxscriptions, so the fatality rate reaches 30-50%. Park Young-min, CEO of HLB Science, said, "While existing antibiotics only remove sepsis-causing bacteria, DD-S052P is a low-toxic synthetic peptide drug that neutralizes endotoxins released by causative bacteria." After successfully completing this phase 1 clinical trial, we plan to proceed with phase 2 global in multiple countries such as the United States and Europe as soon as possible, he said.