Scandinavian Biopharma Announces Publication of ETVAX® Phase 2b Data in The Lancet Infectious Diseases and Confirms Phase 3 Readiness

Scandinavian Biopharma today announces that the comprehensive results from its Phase 2b trial of ETVAX^®, the lead oral vaccine candidate against enterotoxigenic Escherichia coli (ETEC), have been published in The Lancet Infectious Diseases, one of the world’s foremost peer-reviewed medical journals.

The peer-reviewed publication provides detailed analysis of the trial’s safety, immunogenicity, and efficacy outcomes and underscores the global public-health relevance of the ETVAX® programme.

Landmark Lancet Infectious Diseases Publication

The Phase 2b trial enrolled 4,936 infants aged 6–18 months in The Gambia in a randomised, double-blind, placebo-controlled design in collaboration with the MRC Unit The Gambia London School of Hygiene & Tropical Medicine, a leading infectious disease research institution in West Africa.

• Approximately 50% vaccine efficacy against ETEC-positive moderate-to-severe diarrhoea irrespective of co-infections
• 81% vaccine efficacy when enteroparasitic co-infections were excluded
• The trial underscores the importance of vaccinating children early. Among children vaccinated before nine months of age vaccine efficacy reached 68%

Reduced risk for all-cause moderate-to-severe diarrhoea by 21% sustained over the full trial period, 24 months, a level of protection comparable to the all-cause protection observed for rotavirus vaccine which is currently administered to approximately 40 million children in low- and middle-income countries through UNICEF.

The trial confirmed an excellent safety profile and robust systemic immune responses against key ETEC antigens. ETVAX® was estimated to cover more than 90% of circulating ETEC strains in high-burden settings.

EMA Confirms Phase 3 Readiness

Following formal Scientific Advice, the European Medicines Agency (EMA) concluded that the accumulated safety, immunogenicity, and efficacy data support advancement to a pivotal Phase 3 programme. ETVAX® is considered Phase 3 ready for the prevention of moderate-to-severe ETEC diarrhoea in infants and young children in low- and middle-income countries.

Planned Phase 3 Programme and potential Public Health Impact

The planned pivotal Phase 3 trial is expected to enrol approximately 5,800 infants aged 6–9 months in high-burden LMIC settings. The trial will confirm efficacy against moderate-to-severe ETEC-positive diarrhoea and further characterise safety to support global licensure.

Based on Phase 2b efficacy data and assuming implementation at scale through immunisation programs, ETVAX® has the potential to:

• Prevent millions of moderate-to-severe diarrhoeal episodes annually
• Improve child growth and cognitive development
• Reduce inappropriate antibiotic use and contribute to antimicrobial resistance mitigation
• Deliver population-level impact comparable to rotavirus vaccine introduction in high-burden settings

“Publication of our Phase 2b data in The Lancet Infectious Diseases represents an important milestone for Scandinavian Biopharma and the broader ETEC vaccine field,” said Björn Sjöstrand, Chief Executive Officer. “Independent peer-review in one of the world’s leading infectious disease journals confirms the scientific strength and public-health relevance of our data. Together with EMA confirmation that ETVAX® is Phase 3 ready, we are now entering the final clinical stage with strong momentum.”

For further information, please contact:

Björn Sjöstrand
Chief Executive Officer
Scandinavian Biopharma Holding AB
Email: bjorn@scandinavianbiopharma.se