LimmaTech Starts Phase 1 Trial for S. aureus Vaccine LBT-SA7
LimmaTech Vaccinates First Participants in Phase 1 Study of Staphylococcus aureus Vaccine Candidate LBT-SA7
LimmaTech Biologics AG, a clinical-stage biotech company focused on developing vaccines for the prevention of life-threatening diseases, has announced that the first participants have been vaccinated in a Phase 1 controlled study of its multivalent vaccine candidate, LBT-SA7. This investigational vaccine is designed to prevent skin and soft tissue infections (SSTIs) caused by Staphylococcus aureus (S. aureus), a bacterial pathogen that poses a significant global health threat. Additionally, the company has secured US$6.5 million in funding from the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) to support the clinical advancement of LBT-SA7.
Addressing a Critical Global Health Threat
S. aureus infections represent a major public health concern, causing approximately one million deaths worldwide each year. Among these, an estimated 90% of all community-acquired S. aureus infections manifest as SSTIs. Despite the burden of disease, no vaccine currently exists to prevent S. aureus infections. Treatment options remain limited, particularly against antibiotic-resistant strains such as methicillin-resistant S. aureus (MRSA), which complicates infection management and increases the risk of severe complications.
LimmaTech’s novel vaccine candidate, LBT-SA7, represents a major advancement in tackling this challenge. It is the first multivalent vaccine entirely based on secreted antigens, designed specifically to neutralize the bacterial toxins that contribute to S. aureus infections. LBT-SA7 contains weakened forms of these toxins, known as toxoids, which help the immune system recognize and counteract the pathogen’s harmful effects, potentially providing a highly effective means of protection against SSTIs and other severe manifestations of S. aureus infections.
Advancing Clinical Development: Phase 1 Study Underway
LimmaTech initiated a Phase 1 clinical trial (NCT06719219) in the United States following the receipt of a Fast Track designation from the U.S. Food and Drug Administration (FDA). This designation is reserved for promising investigational treatments that address significant unmet medical needs, underscoring the potential impact of LBT-SA7.
The Phase 1 study is a randomized, double-blinded, controlled, dose-escalation trial designed to evaluate the safety, tolerability, and immunogenicity of LBT-SA7. The study aims to enroll 130 healthy adults between the ages of 18 and 50. By systematically assessing different doses, researchers hope to identify an optimal formulation that elicits a strong and protective immune response. The trial’s initial results are anticipated in the second half of 2025, marking a crucial milestone in the development of this vaccine.
Expert Perspectives on the Potential of LBT-SA7
Developing a vaccine against S. aureus has been a long-standing scientific challenge due to the pathogen’s ability to evade the immune system. However, LimmaTech’s approach offers a promising new strategy. By targeting secreted toxins rather than the bacterial cells themselves, the vaccine circumvents some of the challenges that have hindered previous efforts.
Dr. Patricia Martin-Killias, Chief Operating Officer of LimmaTech, emphasized the importance of this breakthrough:
“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.”
Beyond its potential to prevent SSTIs, LBT-SA7 may also help mitigate the economic and healthcare burden associated with antibiotic-resistant infections. Hospital-acquired S. aureus infections, including MRSA, are a major source of prolonged hospital stays, increased medical costs, and higher mortality rates. A successful vaccine could reduce these complications and provide an important tool in global public health efforts.
Strategic Funding and Support from CARB-X
CARB-X, an international partnership dedicated to accelerating research in antimicrobial resistance, has awarded LimmaTech a grant of US$6.5 million to support the clinical development of LBT-SA7. This funding highlights the vaccine’s potential in addressing a major unmet medical need and reinforces the urgency of finding effective preventive solutions for bacterial infections.
Dr. Franz-Werner Haas, Chief Executive Officer of LimmaTech, expressed gratitude for the funding and reiterated the company’s commitment to combating antimicrobial resistance:
“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.”
The Future of LBT-SA7
As the Phase 1 trial progresses, LimmaTech will continue to gather critical safety and efficacy data that will inform subsequent phases of clinical development. If the early results confirm LBT-SA7’s potential, the company will move toward larger Phase 2 and Phase 3 trials to further evaluate its effectiveness across broader patient populations.
With no existing vaccine against S. aureus, the successful development of LBT-SA7 could represent a paradigm shift in infectious disease prevention. By reducing the incidence of SSTIs and lowering the burden of antibiotic resistance, this vaccine could play a pivotal role in global health initiatives aimed at controlling bacterial infections.
