Positive Phase I/II Results for LimmaTech's Shigella Vaccine S4V

Swiss-based LimmaTech Biologics has reported promising interim findings from its Phase I/II clinical trial of Shigella4V (S4V), a novel tetravalent bioconjugate vaccine designed to combat shigellosis, a severe diarrheal disease prevalent in children from low- to middle-income nations. The ailment, caused by Shigella bacteria, is notably the second most common cause of fatal diarrhea globally.

In the trial's targeted demographic of nine-month-old infants, the S4V vaccine exhibited a positive safety profile and high tolerability. It also showed strong immunogenicity against the four primary Shigella serotypes: S. flexneri 2a, 3a, 6, and S. sonnei. The trial, which included Kenyan participants, involved 472 infants receiving two intramuscular injections of varying doses, with or without an adjuvant. The vaccine was well-tolerated, with mild reactions and no serious adverse events attributed to it. A significant rise in serum IgG levels was noted post-injections, contingent on the dosage and formulation.

Patricia Martin, LimmaTech's Chief Operating Officer, emphasized the vaccine's potential to shield infants, a group particularly vulnerable to the disease. She highlighted shigellosis's severity, exacerbated by the pathogen's increasing antibiotic resistance, and expressed optimism for the vaccine's role in safeguarding children, travelers, and military personnel in Shigella-endemic regions. The company anticipates initiating further clinical studies in 2024.

The Phase I/II study in Kenya was structured as a randomized, double-blind trial to gauge the vaccine's safety and immunogenicity across various age groups, focusing on identifying the optimal dosage for infants. LimmaTech's collaboration with GlaxoSmithKline (GSK) and the Wellcome Trust has been instrumental in advancing the development of the multivalent Shigella vaccine, with LimmaTech acquiring the S4V candidate from GSK in July 2023 to spearhead its continued development.

Shigellosis poses a significant global health risk, with an estimated 188 million infections annually, predominantly affecting children under five. The disease leads to substantial morbidity and mortality, especially in endemic areas and among travelers and military personnel. Despite oral rehydration and antibiotics being the standard treatment, the emergence of multidrug-resistant Shigella strains has complicated therapy. Currently, no Shigella vaccine is licensed for use.

LimmaTech Biologics is dedicated to combating antimicrobial resistance through its innovative vaccine technology and clinical development expertise. The company is committed to creating vaccines that address the growing challenge of untreatable infections, leveraging its self-adjuvanting and multi-antigen platform, along with other targeted approaches. With a robust pipeline and a team rich in experience, LimmaTech aims to provide protective solutions with a transformative impact worldwide.