LimmaTech and Valneva awarded FDA Fast Track designation for Shigella vaccine candidate

Fast Track designation is granted by the FDA to products under development that have the potential to treat serious conditions and fill an unmet medical need. It is designed to facilitate the clinical development and expedite the review of important new products with the intention to get them to the people who need them earlier.

Thomas Lingelbach, Chief Executive Officer of Valneva, commented, “Shigellosis is the second leading cause of fatal diarrheal disease worldwide. However, there is currently no approved Shigella vaccine and the development of Shigella vaccines has been identified as a priority by the World Health Organization (WHO). Fast Track designation allows us to work closely with the FDA to accelerate our efforts to deliver a preventative solution against this deadly disease.”

Dr. Franz-Werner Haas, Chief Executive Officer of LimmaTech, stated, “We are highly encouraged by the FDA’s Fast Track designation, which reinforces our efforts and underscores the significant potential of the S4V Shigella vaccine candidate to address a serious global health threat.”

It is estimated that up to 165 million cases of disease and an estimated 600,000 deaths are attributed to Shigella each year, particularly among children in Low- and Middle-Income Countries (LMICs). Shigellosis also affects international travelers from high-income countries and deployed military personnel in endemic regions.

In August 2024, Valneva entered into a strategic partnership and exclusive licensing agreement with LimmaTech for the development, manufacturing and commercialization of S4V. Following positive Phase 1/2 results earlier this year, LimmaTech will conduct a Phase 2 Controlled Human Infection Model study (CHIM) in the U.S. and a Phase 2 pediatric study in LMICs, both expected to begin before the end of 2024. Valneva will assume all further development, including CMC (chemistry, manufacturing and controls) and regulatory activities, and be responsible for its commercialization worldwide, if approved.

The anticipated regulatory pathway for S4V will leverage a combination of CHIM studies to support potential initial approval in adults followed by field efficacy studies to potentially expand the indication to children.

About Shigellosis
Shigellosis is a global health threat caused by the Gram-negative Shigella bacteria. It is estimated that up to 165 million infections are due to Shigella of which 62.3 million occur in children younger than five years. Diarrheal infection is one of the major causes of morbidity and mortality in numerous countries as well as in travelers and deployed military personnel in endemic regions. There are an estimated 600,000 deaths attributed to Shigella each year and it is the second leading cause for diarrheal deaths. The standard treatment for shigellosis is oral rehydration and antibiotic therapy, however, the bacteria have acquired resistance to many antibiotics with numerous reports of outbreaks of multidrug-resistant strains, making treatment extremely difficult. Currently, no licensed Shigella vaccine is available.