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Bharat Biotech on Thursday announced its partnership with UK-based pharma company GSK for the development and potential use of the Shigella vaccine candidate altSonflex1-2-3.
As part of the agreement, Bharat Biotech will lead the further development of altSonflex1-2-3, including Phase 3 clinical trials, regulatory advancement and large-scale manufacturing.
GSK, on the other hand, will support the programme by assisting with clinical trial design, securing external funding and contributing to the access and delivery plans and commercialisation strategy.
The company said that the agreement marks a significant step in advancing the vaccine, which targets shigellosis, a severe form of bacterial diarrhoea that disproportionately affects children under five years of age in low- and middle-income countries (LMICs).
‘The vaccine candidate has already demonstrated a strong safety and immunogenicity profile in both European and African trials, including in the primary target population of nine-month-old infants,’ it added.
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Commenting on the development, Krishna Ella, Executive Chairman at Bharat Biotech, said that with no approved vaccine currently available and antimicrobial resistance on the rise, there is an urgent need for scalable, science-backed solutions focused on LMICs.
‘This collaboration combines our strengths in innovation, manufacturing and global health commitment.’
According to the World Health Organisation (WHO), Shigella was the second-leading cause of diarrhoeal mortality in 2016 (latest data) among all ages and the leading bacterial cause of diarrhoea, accounting for approximately 212,000 deaths and about 13 per cent of all diarrhoea-associated deaths.
The disease is a major contributor to child morbidity and mortality, and the emergence of drug-resistant strains underscores the urgent need for a preventive vaccine.
The standard of care for shigellosis primarily involves managing dehydration and using antibiotics. While mild cases often resolve with rest and fluid replacement, more severe cases or those with weakened immune systems may benefit from antibiotics like ciprofloxacin or azithromycin.
Thomas Breuer, Chief Global Health Officer at GSK, said that by helping reduce illness and antibiotic use, this vaccine has the potential to play a critical role in combating antimicrobial resistance (AMR).
The companies claimed that the vaccine candidate has broad serotype coverage, an innovative Generalised Modules for Membrane Antigens (GMMA)-based platform and robust early clinical results.
‘GMMA technology is a platform that uses bacterial outer membranes to deliver the O antigen to the immune system, allowing for high-yield production, which creates affordable vaccines for underserved populations,’ they added in a statement.
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