LimmaTech receives fast-track status for Shigella vaccine

The US Food & Drug Administration(FDA) has granted fast-track status to LimmaTech Biologics ' Shigella vaccine candidate S4V. This is awarded to products under development that have the potential to treat serious diseases and meet an unmet medical need. This status enables an accelerated review process and, if successful, faster approval.

The tetravalent vaccine candidate would be the first approved preventive vaccine against shigellosis, the second most common cause of fatal diarrheal diseases worldwide. It is estimated that up to 165 million cases of illness and around 600,000 deaths are attributed to Shigella each year, particularly among children in low- and middle-income countries. Shigellosis also affects international travelers and military personnel sent to endemic regions.

"We are very encouraged by the FDA's fast-track classification," said LimmaTech CEO Dr. Franz-Werner Haas in a statement. "This reinforces our efforts and underlines the significant potential of the S4V Shigella vaccine candidate to combat a serious global health threat."

Following the positive Phase 1/2 results at the beginning of the year, LimmaTech will conduct a Phase 2 trial in the USA with a controlled human infection model and a Phase 2 trial in children in poorer countries. Both are expected to begin before the end of 2024.

The French company Valneva is responsible for further development, production and marketing. LimmaTech, which was founded in Bio-Technopark Schlieren-Zurich, concluded a corresponding exclusive license agreement in August 2024. ce/mm