LimmaTech Awarded FDA Fast Track Designation for Vaccine Candidate Against Staphylococcus aureus

Schlieren (Zurich), December 19, 2024 – LimmaTech Biologics AG, a clinical-stage biotech company developing vaccines for the prevention of life-threatening diseases, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to LimmaTech’s 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.”

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.