The trial is being conducted by LimmaTech Biologics, and the first participants have been vaccinated.
Produced by the National Institute of Allergy and Infectious Diseases (NIAID), this digitally colorized, scanning electron microscopic (SEM) image, depicts a clump of yellow-colored, spheroid shaped, Staphylococcus aureus bacteria that were enmeshed in a blue-colored, filamentous extracellular matrix, which normally binds cells together within the body’s various tissue types.
Image credit: National Institute of Allergy and Infectious Diseases (NIAID)
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.
Learn more: Clinical Care and Management for Patients Hospitalized With Staphylococcus aureus
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 skin and soft tissue infections, bloodstream infections, pneumonia, and osteomyelitis. In healthcare settings, infections can lead to serious or fatal outcomes.2 MRSA, in particular, remains a problematic infection to treat.2
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.
