FDA Grants Fast Track Designation to Valneva and LimmaTech's Shigella4V Vaccine

Valneva SE, a specialty vaccine company, and LimmaTech Biologics AG, a clinical-stage biotech firm focused on preventing life-threatening diseases, have announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Shigella4V (S4V). Shigella4V is the world’s most clinically advanced tetravalent bioconjugate shigellosis vaccine candidate, for which Valneva has obtained an exclusive worldwide license from LimmaTech.

Publish Date: 16-10-2024 Source: Valneva SE

Shigellosis is a bacterial infection caused by members of the genus Shigella, which belong to the tribe Escherichia in the family Enterobacteriaceae. The condition affects the digestive system and has two basic clinical presentations: watery diarrhoea associated with vomiting, mild to moderate dehydration, and dysentery characterized by a small volume of bloody mucoid stools and abdominal pain. The average duration of symptoms in untreated adults is seven days. Shigella species differentiated into four species: S dysenteriae (serogroup A, consisting of 12 serotypes); S flexneri (serogroup B, consisting of 6 serotypes); S. boydii (serogroup C, consisting of 18 serotypes); and S. sonnei (serogroup D, consisting of a single serotype). The hallmarks of shigellosis are the bacterial invasion of the colonic epithelium and inflammatory colitis, which results in the characteristic sign of bacillary dysentery: scanty, unformed stools tinged with blood and mucus. The diagnosis of shigellosis is usually confirmed by the cultivation of the etiologic agent from stools and slide agglutination using commercially available, absorbed rabbit antisera.

Approximately 500,000 cases of shigellosis are estimated to occur annually in the United States.

However, the current Shigellosis treatment market share, market uptake, and attribute analysis concerning the most potential emerging therapies (Bacteriophage, ShigETEC live, Tebipenem Pivoxil, etc..) has been provided under the market outlook section of the study covering 8 MM countries; The United States, EU5 (Germany, Spain, France, Italy, UK) Japan and China.

In terms of pharmacologic therapies, several pharmaceutical products are being approved and under different phases of development for the Shigellosis treatment. The key companies in the advanced development stage are Intralytix, Inc., Eveliqure Biotechnologies GmbH, GlaxoSmithKline, etc..

Based on solid domain and business knowledge, Thelansis Knowledge Partners has published the market outlook forecast report on Shigellosis to provide a clear understanding of disease area background, epidemiology, current and future competitions, the country-specific standard of care, and the complete market forecast for 2023 to 2033.

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