LimmaTech Biologics AG, a clinical-stage biotech company focused on developing vaccines for life-threatening diseases, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its multivalent toxoid vaccine candidate, LBT-SA7. The vaccine is 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 with the potential to treat serious conditions and address unmet medical needs. This designation accelerates the review process by allowing more frequent interactions with the FDA to discuss clinical development plans. For LimmaTech, this means a quicker path to getting their new product, LBT-SA7, to patients.
Dr. Franz-Werner Haas, CEO of LimmaTech, highlighted the urgency of finding effective solutions for Staphylococcus aureus (S. aureus) infections. “S. aureus infections are a major cause of global mortality, with rising antibiotic resistance making traditional treatments less effective. Despite the critical need, no vaccine currently exists to prevent these infections. The Fast Track designation allows us to speed up the development of a vaccine that can prevent the recurrence of skin and soft tissue infections (SSTIs) caused by S. aureus,” he said.
S. aureus is responsible for over a million deaths annually. Around 90% of community-acquired S. aureus infections are SSTIs, which LBT-SA7 aims to address. The vaccine contains weakened toxins, known as toxoids, that neutralize the harmful effects of the pathogen’s toxins, preventing infection.
Dr. Michael Kowarik, Chief Scientific Officer of LimmaTech, explained, “LBT-SA7 offers a novel approach to vaccine development by neutralizing the toxins released by S. aureus, thus preventing their harmful effects.” The Phase 1 clinical trial will assess the vaccine’s safety in healthy volunteers and confirm its ability to neutralize toxins.
The Phase 1 study will be a randomized, double-blinded, dose-escalation trial at a clinical center in the U.S. It will involve 130 participants aged 18-50 years and focus on the vaccine’s safety and immunogenicity. Initial results are expected in the second half of 2025.
The research for this project is supported by CARB-X, with funding from the U.S. Department of Health and Human Services (HHS), Wellcome, 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).
About Staphylococcus aureus
S. aureus, a Gram-positive bacterium, affects approximately 30% of the human population and causes a wide range of infections, from mild SSTIs to severe conditions such as pneumonia and bloodstream infections. It is a leading cause of antimicrobial resistance (AMR)-related deaths. SSTIs can range from mild to severe, involving infection of the skin and underlying tissues. Antibiotics are becoming less effective due to rising resistance, which makes innovative vaccines and treatment strategies urgently needed.
About LimmaTech Biologics AG
LimmaTech Biologics is dedicated to addressing the global antimicrobial resistance crisis with its innovative vaccine technology. The company uses its proprietary multi-antigen vaccine platform to develop solutions for untreatable microbial infections. LimmaTech is backed by leading healthcare investors such as Adjuvant Capital, AXA IM Alts, Novo Holdings REPAIR Impact Fund, and Tenmile.
