LimmaTech Begins Phase 1 Trial of Staphylococcus aureus Vaccine LBT-SA7
LimmaTech Biologics AG, a clinical-stage biotech company focused on developing vaccines for life-threatening diseases, announced the vaccination of the first participants in a Phase 1 controlled study of its multivalent vaccine candidate, LBT-SA7. This vaccine aims to prevent skin and soft tissue infections (SSTIs) caused by the bacterial pathogen Staphylococcus aureus (S. aureus). Additionally, the company revealed it has been awarded US$6.5 million from the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) to support the ongoing clinical development of LBT-SA7.
Staphylococcus aureus infections present a significant global health risk, causing an estimated 1 million deaths each year. A major concern is that 90% of all community-acquired S. aureus infections result in skin and soft tissue infections (SSTIs). The lack of a vaccine to prevent these infections, along with limited treatment options, especially for multidrug-resistant strains like methicillin-resistant S. aureus (MRSA), emphasizes the urgent need for effective preventive measures. LimmaTech Biologics is addressing this challenge with its innovative vaccine candidate, LBT-SA7, the first multivalent vaccine based on secreted antigens, aimed at combating this widespread bacterial threat.
LBT-SA7 works by incorporating weakened forms of the toxins produced by S. aureus, known as toxoids. These toxoids are designed to neutralize the harmful toxins secreted by the pathogen, offering a promising strategy for preventing infections. By targeting the toxins directly, LBT-SA7 could play a pivotal role in controlling S. aureus infections, including those caused by drug-resistant strains, which remain a major public health concern.
LimmaTech began a Phase 1 clinical trial for LBT-SA7 (NCT06719219) in the U.S., following the granting of Fast Track designation by the U.S. Food and Drug Administration (FDA). This first-in-human study is designed to assess the safety and immune response generated by LBT-SA7 in healthy adults aged 18-50 years. The trial is randomized, double-blinded, and dose-escalation, with the goal of enrolling 130 participants. Results are expected in the second half of 2025, bringing the vaccine one step closer to potential public use.
Dr. Patricia Martin-Killias, Chief Operating Officer of LimmaTech, commented on the importance of the vaccine, saying, “Developing an S. aureus vaccine has long been a significant scientific challenge. We believe LBT-SA7 has the potential to provide a much-needed solution for those suffering from S. aureus infections. We are excited to launch the first-in-human clinical trial for LBT-SA7, bringing us closer to addressing an urgent global health challenge.”
Dr. Franz-Werner Haas, Chief Executive Officer of LimmaTech, highlighted the invaluable support from CARB-X, a global partnership aimed at accelerating the development of innovative antibiotics and vaccines. “We are grateful for the significant support from CARB-X, which is instrumental in advancing LBT-SA7’s clinical development. This collaboration underscores the importance of our mission to develop effective solutions for preventing microbial infections and protecting people from their devastating consequences,” he added.
Research efforts for this project are supported by CARB-X, with funding from the U.S. Department of Health and Human Services (HHS), the Biomedical Advanced Research and Development Authority (BARDA), 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). This funding support highlights the global significance of the initiative and the collective efforts to combat antimicrobial resistance (AMR).
Staphylococcus aureus, a Gram-positive bacterium, affects approximately 30% of the human population and is responsible for a wide range of infections, from mild skin conditions to severe pneumonia and bloodstream infections. As a leading cause of deaths linked to antimicrobial resistance, S. aureus continues to pose a major health challenge in both community and hospital settings. Skin and soft tissue infections (SSTIs) caused by S. aureus are particularly common and can range from mild to severe, requiring various treatment approaches. However, the rise of antibiotic-resistant strains has made traditional treatments less effective, emphasizing the need for new strategies to control the pathogen.
S. aureus has been classified by the World Health Organization (WHO) as a “high priority” pathogen, signaling the urgent need for innovative vaccines and alternative treatments to address its growing threat. LimmaTech Biologics is positioning itself at the forefront of the fight against antimicrobial resistance, leveraging its expertise in vaccine technology and clinical candidate development.
The company’s self-adjuvanting, multi-antigen vaccine platform forms the foundation of its pipeline, aimed at preventing microbial infections that are increasingly difficult to treat. LimmaTech is dedicated to developing protective vaccines with the potential to deliver transformative solutions globally. Backed by healthcare investors like Adjuvant Capital, AXA IM Alts, Novo Holdings REPAIR Impact Fund, and Tenmile, LimmaTech is advancing its mission to combat infectious diseases and safeguard public health.
As the clinical trial for LBT-SA7 progresses, the world waits to see if this promising vaccine can ultimately help tackle one of the most pressing health challenges of our time. With growing concerns over antibiotic resistance and the prevalence of S. aureus infections, a successful vaccine could mark a significant step forward in the global fight against antimicrobial resistance.
