HLB Science Expands Scope with Sepsis Treatment Clinical Trials in the US

HLB Science, a peptide-based new drug development specialist, announced on the 10th that it has applied to the U.S. Food and Drug Administration (FDA) for a change in the clinical trial plan for the sepsis treatment ‘DD-S052P’ in Phase 1.

The Phase 1 clinical trial of DD-S052P, which has been underway since receiving approval from the French National Agency for the Safety of Medicines and Health Products (ANSM) in July 2022, will continue in the United States. Reflecting the FDA’s review comments, some contents of the existing clinical trial protocol, such as subject inclusion/exclusion criteria and the number of screening schedules, were also partially revised.

The reason HLB Science is continuing the clinical trial in the U.S. is that the U.S. sepsis treatment market is the largest in the world, allowing for faster clinical progress, and it will be easier to expand the clinical trials globally based on the U.S. Phase 1 clinical results.

It was also considered advantageous to pursue global partnerships if the efficacy of the new drug is confirmed in the sepsis treatment field, where there are no adequate treatments other than antibiotics. The Phase 1 trial will be completed in the U.S. next year, followed by expansion to a global scale.

DD-S052P is a low-toxicity synthetic peptide new drug with a dual-action mechanism that not only targets the elimination of causative bacteria, unlike existing antibiotics that focus solely on removing sepsis-causing bacteria, but also neutralizes endotoxins released by the causative bacteria.

Sepsis is characterized by a cytokine storm (immune hypersensitivity reaction), which occurs when bacteria invade the body and spread systemically through the bloodstream, triggering an excessive immune response to endotoxins released by bacteria and other pathogens. Existing antibiotics cannot resolve such systemic inflammatory responses. This is why DD-S052P is attracting attention as a fundamentally innovative treatment.

Yoon Jong-sun, CEO of HLB Science, said, "The FDA IND change application is part of our global market entry strategy, and we decided that expanding clinical trials in the U.S., where the sepsis treatment market is the largest, is advantageous for rapid new drug development."