The trial is being conducted by LimmaTech Biologics, and the first participants have been vaccinated.
Munich, Germany-based LimmaTech Biologics AG, announced yesterday that the first participants of a phase 1 trial have been vaccinated with the company’s multivalent vaccine candidate, LBT-SA7. The candidate is designed to prevent skin and soft tissue infections (SSTIs) caused by Staphylococcus aureus (S aureus).
“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,” LimmaTech Chief Operating Officer Patricia Martin-Killias, ScD, said in a statement.
LimmaTech received a Fast Track designation from FDA, and 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.
The clinical-stage biotech company, which develops vaccines for the prevention of diseases, also announced the award of $6.5 million from the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) to advance the clinical development of the vaccine.
“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,” Limma CEO Franz-Werner Haas, PhD, said in a statement.
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The first participants have been vaccinated, and the study will assess the safety and immunogenicity of the vaccine in 130 healthy adults aged 18-50 years.
The vaccine has received Fast Track designation from the FDA, indicating its potential to address a significant unmet medical need.
LimmaTech has received $6.5 million from the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) to support the clinical development of LBT-SA7.
S aureus is a bacterium commonly found on the skin and in the nose of about 30% of individuals according to the Centers for Disease Control and Prevention (CDC).2 Although S aureus does not cause any harm, it can sometimes cause infections. It can present in a number of ways including
S aureus is the leading cause of antimicrobial resistance (AMR)-attributed fatalities with community-acquired and hospital-acquired infections being the most prevalent. S aureus infections cause an estimated 1 million deaths annually. Notably, 90% of all community-acquired S. aureus infections are SSTIs.
LimmaTech said it expects initial results from the study in the second half of 2025.
