LimmaTech Vaccinates First Participants in Phase 1 Study of Staphylococcus aureus Vaccine Candidate LBT-SA7
, a clinical-stage biotech company developing vaccines for the prevention of life-threatening diseases, announced today that the first participants have been vaccinated in a Phase 1 controlled study of its multivalent vaccine candidate, LBT-SA7. The candidate is designed to prevent skin and soft tissue infections (SSTIs) caused by the bacterial pathogen Staphylococcus aureus ( S. aureus). In this context, the company also announced the award of US$6.5 million from the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) to advance the clinical development of LBT-SA7.
S. aureus infections pose a significant global health challenge, causing an estimated 1 million deaths annually. Notably, 90% of all community-acquired S. aureus infections are SSTIs. The absence of a vaccine to prevent S. aureus, coupled with only limited treatment options - particularly against multidrug-resistant strains of the pathogen, often described as methicillin-resistant S. aureus (MRSA) - highlights the urgent need for effective preventive solutions. LimmaTech's vaccine candidate, LBT-SA7, is the first multivalent vaccine entirely based on secreted antigens to address this critical need. LBT-SA7 contains weakened forms of the pathogen's toxins, referred to as toxoids, designed to prevent infections by neutralizing the toxins secreted by S. aureus. This approach offers a promising solution to combat the widespread bacterial threat.
LimmaTech started a Phase 1 clinical trial ( NCT06719219) in the U.S. after receiving a Fast Track designation from the U.S. Food and Drug Administration (FDA). This first-in-human study aims to evaluate the safety and immunogenicity of LBT-SA7 against S. aureus. It is a randomized, double-blinded, and controlled dose-escalation study expected to enroll 130 healthy adults aged 18-50 years. Initial results are anticipated in the second half of 2025.
'Developing an S. aureus vaccine has long been a significant scientific challenge,' explained Dr. Patricia Martin-Killias, Chief Operating Officer of LimmaTech. '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.'
'We are grateful for the significant support from CARB-X, which is not only instrumental in accelerating the clinical development of our S. aureus vaccine candidate LBT-SA7 but also underscores the importance of our mission to develop efficient solutions for preventing microbial infections and protecting from their threatening consequences for affected people,' added Dr. Franz-Werner Haas, Chief Executive Officer of LimmaTech.
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.
About LimmaTech Biologics AG
LimmaTech Biologics is at the forefront of combating the global antimicrobial resistance epidemic based on its unparalleled track record in vaccine technology and clinical candidate development. The company is leveraging its proprietary self-adjuvanting and multi-antigen vaccine platform alongside additional disease-specific vaccine approaches to prevent increasingly untreatable microbial infections. With decades of expertise and an expanding, robust pipeline, the LimmaTech team is dedicated to generating protective solutions to deliver transformative value worldwide. LimmaTech Biologics is backed by specialist healthcare investors, including Adjuvant Capital, AXA IM Alts, Novo Holdings REPAIR Impact Fund, and Tenmile. For more information, please visit www.lmtbio.com.
Franz-Werner Haas, CEO
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SOURCE: LimmaTech Biologics AG
Copyright Business Wire 2025.
PUB: 02/17/2025 04:00 AM/DISC: 02/17/2025 04:02 AM
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