FDA Awards Fast Track Designation to Staphylococcus aureus Vaccine Candidate

The FDA granted fast track designation (FTD) to a multivalent toxoid vaccine candidate from LimmaTech, LBT-SA7, which is designed to prevent skin and soft tissue infections (SSTIs) caused by the bacteria Staphylococcus aureus (S aureus), according to a news release from LimmaTech Biologics.¹

Staph infections caused by Staphylococcus aureus could be life-threatening if acquired in a health care setting. | Image Credit: © Екатерина Шпаченко | stock.adobe.com

“Staphylococcus aureus infections are a major cause of global mortality and morbidity, with traditional antibiotic treatments becoming increasingly ineffective due to rising antibiotic resistance,” Franz-Werner Haas, chief executive officer of LimmaTech, said in the news release, noting that no vaccine is currently available to prevent complications stemming from S. aureus infection.¹

“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,” Haas said. FTD allows for products under development that could treat or prevent serious illnesses to receive expedited review, with the goal of patients receiving a new medication as early as possible.¹

According to the CDC, S aureus (staph) is a form of germ found in about 30% of people’s noses, oftentimes not causing any harm. However, the bacteria can sometimes cause staph infections, which can be especially serious or fatal in health care settings.²

More than 1 million deaths are estimated to be attributed to S aureus each year, with 90% of all community-acquired infections being SSTIs. Accordingly, the infection is the leading cause of antimicrobial resistance-attributed fatalities. The LBT-SA7 vaccine candidate includes weakened forms of S aureus’ toxoids to prevent infections by neutralizing the toxins that the pathogen would secrete to cause an infection.¹

Patients most at risk of staph infections in the community are those who inject drugs for disease management or those with chronic conditions, including cancer or diabetes. In health care settings, patients at higher risk for more serious infection include those with weakened or suppressed immune systems, patients with medical devices in their bodies, patients who have undergone specific types of surgeries, and those in intensive care units.²

LBT-SA7 is set to be examined further in a randomized, double-blinded, controlled-dose escalation phase 1 study at a clinical trial center in the United States, including 130 participants aged 18 to 50 years, according to the news release. In the trial, the safety and immunogenicity of the vaccine will be analyzed, with preliminary results expected in the second half of 2025.¹

Innovative treatment approaches to diseases that require antibiotics are becoming more recognized as an essential need as traditional antibiotic treatments—both oral antibiotics and those administered intravenously for severe cases—become increasingly less effective due to antibiotic resistance. Given this, the World Health Organization has designated S aureus as a “high priority” pathogen.¹

“LBT-SA7 represents a fundamentally novel approach to Staphylococcal vaccine development, designed to neutralize toxins and prevent their harmful effects on affected people,” Michael Kowarik, chief scientific officer of LimmaTech, said in the news release. “Our phase 1 clinical trial aims to demonstrate the safety of our vaccine candidate in healthy volunteers and confirm the toxin-neutralizing activity induced by the vaccine.”¹

Pharmacists should remain aware of clinical trial updates regarding this potential vaccine, as a future approval could offer new treatment options for patients dealing with this infection, especially those for which traditional treatment options are ineffective.

REFERENCES

1. LimmaTech Biologics AG. LimmaTech awarded FDA fast track designation for vaccine candidate against Staphylococcus aureus. BusinessWire. Released December 19, 2024. Accessed December 20, 2024. https://www.businesswire.com/news/home/20241219504299/en/LimmaTech-Awarded-FDA-Fast-Track-Designation-for-Vaccine-Candidate-Against-Staphylococcus-aureus

2. CDC. Staphylococcus aureus basics. Last updated April 15, 2024. Accessed online December 20, 2024. https://www.cdc.gov/staphylococcus-aureus/about/index.html