FDA Grants Fast Track Designation to LimmaTech's Staphylococcus aureus Vaccine Candidate

Key Insights

• LimmaTech's LBT-SA7, a multivalent toxoid vaccine, receives FDA Fast Track designation for preventing Staphylococcus aureus skin and soft tissue infections (SSTIs).
• The FDA's decision aims to expedite LBT-SA7's development, allowing more frequent engagement with LimmaTech to address the unmet need for an S. aureus vaccine.
• LBT-SA7 targets the toxins secreted by S. aureus, offering a novel approach to prevent SSTIs, which account for 90% of community-acquired S. aureus infections.

LimmaTech Biologics AG announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its vaccine candidate, LBT-SA7, designed to prevent skin and soft tissue infections (SSTIs) caused by Staphylococcus aureus. This designation aims to accelerate the development and review process for this potentially life-saving vaccine, addressing a critical unmet need in combating S. aureus infections.

Addressing a Critical Need

Staphylococcus aureus infections pose a significant global health threat, contributing to over 1 million deaths annually. The rise of antibiotic resistance has further complicated treatment, making innovative prevention strategies like vaccination increasingly important. Currently, no vaccine is available to prevent the consequences of an S. aureus infection.

"Staphylococcus aureus infections are a major cause of global mortality and morbidity, with traditional antibiotic treatments becoming increasingly ineffective due to rising antibiotic resistance," said Dr. Franz-Werner Haas, Chief Executive Officer of LimmaTech. "The FDA’s Fast Track designation for LBT-SA7 allows us to accelerate the development of a much-needed solution for SSTIs by effectively preventing recurrence."

LBT-SA7: A Novel Approach

LBT-SA7 is a multivalent toxoid vaccine designed to neutralize the toxins secreted by S. aureus, preventing them from causing harm. This approach is particularly relevant as 90% of community-acquired S. aureus infections manifest as SSTIs. The vaccine contains weakened forms of the pathogen’s toxins, stimulating an immune response without causing disease.

"LBT-SA7 represents a fundamentally novel approach to Staphylococcal vaccine development, designed to neutralize toxins and prevent their harmful effects on affected people," explained Dr. Michael Kowarik, Chief Scientific Officer of LimmaTech.

Clinical Development

LBT-SA7 is currently undergoing a Phase 1 clinical trial in the U.S., involving 130 healthy volunteers aged 18-50 years. This randomized, double-blinded, and controlled dose-escalation study aims to evaluate the safety and immunogenicity of the vaccine candidate. Initial results from the Phase 1 trial are expected in the second half of 2025.

The study is designed to assess the safety profile of LBT-SA7 and to confirm that the vaccine induces the desired toxin-neutralizing activity. Participants will receive two injections of either the vaccine candidate, a combination of vaccine and placebo, or two doses of placebo.

Fast Track Designation

The FDA's Fast Track designation is granted to expedite the development and review of new drugs and vaccines that demonstrate the potential to treat serious conditions and address unmet medical needs. This designation allows LimmaTech to engage more frequently with the FDA, facilitating a more efficient development process.

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.