LimmaTech awarded FDA fast track designation for vaccine against Staphylococcus aureus

The FDA grants Fast Track designation to products under development that have the potential to treat or prevent serious conditions and address an unmet medical need. The Fast Track designation is designed to expedite the review by enabling LimmaTech to engage more frequently with the FDA to discuss LBT-SA7’s clinical development plan. The designation aims to get important new products to patients and individuals earlier.

Dr. Franz-Werner Haas, Chief Executive Officer of LimmaTech, commented, “Staphylococcus aureus infections are a major cause of global mortality and morbidity, with traditional antibiotic treatments becoming increasingly ineffective due to rising antibiotic resistance. Despite this urgent medical need, no vaccine is currently available to prevent the consequences of an S. aureus infection. The FDA’s Fast Track designation for LBT-SA7 allows us to accelerate the development of a much-needed solution for SSTIs by effectively preventing recurrence.”

It is estimated that more than 1 million deaths are attributed to S. aureus each year. Notably, 90% of all community-acquired S. aureus infections are SSTIs, which LBT-SA7 aims to address. The vaccine candidate contains weakened forms of the pathogen’s toxins, referred to as toxoids, to prevent infections by neutralizing the toxins the pathogen would otherwise secrete to cause an infection.

“LBT-SA7 represents a fundamentally novel approach to Staphylococcal vaccine development, designed to neutralize toxins and prevent their harmful effects on affected people,” explained Dr. Michael Kowarik, Chief Scientific Officer of LimmaTech. “Our Phase 1 clinical trial aims to demonstrate the safety of our vaccine candidate in healthy volunteers and confirm the toxin-neutralizing activity induced by the vaccine.”

LBT-SA7 will be tested in a randomized, double-blinded, and controlled dose-escalation Phase 1 study at a clinical trial center in the U.S., including 130 participants aged 18-50 years. The trial aims to evaluate the safety and immunogenicity of the vaccine candidate, with initial results anticipated in the second half of 2025.

Research reported in this press release is supported by CARB-X. CARB-X’s funding for this project is provided in part with federal funds from the U.S. Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority; under agreement number: 75A50122C00028, and by awards from Wellcome (WT224842), Germany’s Federal Ministry of Education and Research (BMBF), and the UK Department of Health and Social Care as part of the Global Antimicrobial Resistance Innovation Fund (GAMRIF). The content of this press release is solely the responsibility of the authors and does not necessarily represent the official views of CARB-X or any of its funders.

About Staphylococcus aureus
Staphylococcus aureus (S. aureus), a Gram-positive bacterial pathogen, affects approximately 30% of the human population while causing a spectrum of infections, from SSTI to severe conditions like pneumonia and bloodstream infections. S. aureus is the leading cause of antimicrobial resistance (AMR)-attributed fatalities with community- acquired and hospital-acquired infections being the most prevalent. SSTIs caused by S. aureus range from mild to severe and entail microbial invasion into the skin layers and underlying soft tissues. Traditional antibiotic treatments, both oral therapy and intravenous administration reserved for severe cases, have become increasingly less effective due to the rise of antibiotic resistance. S. aureus has been designated as a "high priority" pathogen by the World Health Organization (WHO), underscoring the urgency for innovative vaccine approaches and effective treatment strategies.