Staphylococcus aureus vaccine candidate receives FDA Fast-Track designation
Switzerland based clinical-stage biotech company, LimmaTech Biologics, announced recently that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to their multivalent toxoid vaccine candidate, LBT-SA7, designed to prevent skin and soft tissue infections (SSTIs) caused by the bacterial pathogen, Staphylococcus aureus (S. 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.”
The company says the safety and immunogenicity of LBT-SA7 will be tested in a phase 1 clinical trial in the United States involving 130 participants aged 18 to 50 years, with initial results reported in the second half of 2025.
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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 communityacquired 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.