Clinical Trials
12
2 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
2015
Active, not recruiting
2
16.7%
Completed
7
58.3%
Recruiting
3
25.0%
No approval data available
• LimmaTech Biologics' LBT-SA7 vaccine candidate receives FDA Fast Track designation to prevent Staphylococcus aureus skin and soft-tissue infections. • The multivalent toxoid vaccine addresses the urgent need for new treatments due to increasing antibiotic resistance and the lack of available vaccines. • A Phase 1 clinical trial involving 130 participants aged 18-50 is planned, with initial results expected in the second half of 2025. • The FDA's decision highlights its commitment to addressing serious health threats and facilitating the development of innovative medical solutions.
• Valneva and LimmaTech's Shigella4V (S4V), a tetravalent bioconjugate vaccine candidate, has received FDA Fast Track designation, aimed at expediting the development of treatments for serious conditions. • Shigellosis, caused by Shigella bacteria, affects up to 165 million people annually, resulting in approximately 600,000 deaths, particularly impacting children in low- and middle-income countries. • LimmaTech will conduct Phase 2 trials, and Valneva will handle further development, CMC, regulatory activities, and commercialization, with plans to leverage CHIM studies for initial adult approval. • The Fast Track designation will facilitate closer collaboration with the FDA to accelerate the delivery of a preventative solution against Shigella, addressing a critical unmet medical need.
