On July 2, HLB Science announced that it has completed dosing for the Phase 1 clinical trials of 'DD-S052P', a treatment for sepsis and Gram-negative superbug infections, in both France and the United States. The company expects to receive the final Clinical Study Report (CSR) by the end of August.
The Phase 1 trial was conducted with healthy subjects to evaluate the safety, tolerability, and pharmacokinetics of DD-S052P through single and multiple ascending dose administrations. The trial began in France, where the feasibility of further development was assessed, and was completed in the United States. HLB Science is currently proceeding with a full-scale analysis of the clinical sample data. Data lock-up has been completed for the French clinical data, while the data lock-up process for the U.S. clinical data is still underway.
Based on the clinical results, HLB Science is reviewing a range of indications, including the potential for combination therapies. The company plans to submit and obtain approval for the next Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) within this year. HLB Science is focusing its capabilities on product commercialization through technology transfer or joint development with global pharmaceutical companies in the future.
Recently, as the risk of superbug infections has surged worldwide, the need for new antibiotic development has become more pronounced. Additionally, with no new antibiotic substances reported for decades, a report by the UK government (Jim O'Neill Report) projected that, if antibiotic resistance is not properly addressed, 10 million people could die annually worldwide by 2050.
Sepsis is a fatal disease that leads to severe systemic infection and organ damage, yet there are no appropriate treatments other than antibiotic prescriptions. The mortality rate reaches 50 to 70 percent. As the death rate from sepsis continues to rise, the development of effective treatments has emerged as a global public health challenge. Superbugs resistant to existing antibiotics are appearing frequently, making the development of new drugs to overcome this resistance an urgent need.
HLB Science's 'DD-S052P' is a novel peptide drug that binds to endotoxins (LPS) derived from Gram-negative bacteria, the main cause of sepsis, and directly kills the bacteria. The drug is expected to overcome the resistance issues faced by conventional antibiotics and provide a new treatment alternative for sepsis patients.
An HLB Science official stated, "Currently, the effectiveness of existing treatments in the antibiotic market is being limited more rapidly than expected due to resistance issues," adding, "Global pharmaceutical companies are also showing great interest in the development of new antibiotics such as DD-S052P."
The official continued, "Through this Phase 1 trial, HLB Science will secure an important opportunity to enter the global infectious disease market," and added, "Lastly, to meet the future demands of overcoming the antibiotic crisis for humanity, significant investment in research and development is required, and we hope for a sustainable market environment."
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