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Scandinavian Biopharma and PATH sign collaborative development agreement after successful Phase I study of a novel vaccine candidate against diarrheal disease.

Travelers’ diarrhea is the leading cause of illness among international travelers to developing countries. Enterotoxigenic Escherichia coli (ETEC) bacteria are the primary cause of this disease. ETEC is also a major cause of diarrheal disease among children living in endemic countries, leading to over 400 million diarrheal episodes and approximately 300,000 deaths each year. Today there is no ETEC vaccine available to address these unmet needs.

The international global health nonprofit organization PATH and Scandinavian Biopharma have agreed to continue their collaboration to develop a novel vaccine candidate against diarrhea caused by ETEC. Impressive results obtained in a recently conducted clinical Phase I study triggered this decision. PATH supports the project by providing expertise, know-how, and financial resources.

The clinical Phase I study showed very encouraging results. All primary endpoints were exceeded. The vaccine candidate was safe and well tolerated by the study participants. There was a high frequency of response, as 83 percent of the subjects responded to all five of the primary vaccine components; this result exceeds the primary immunological endpoint for the study (at least 50 percent of the subjects responding to at least four of the primary vaccine antigens).

Together, the partners will continue the development of this vaccine candidate in the effort to prevent and control ETEC-related illness and mortality among infants and young children living in ETEC-endemic areas, as well as to prevent ETEC-associated travelers’ diarrhea occurring among international travelers.

The development of this new ETEC vaccine candidate is a collaborative effort among Scandinavian Biopharma, the University of Gothenburg, and PATH.

 

For more information, please contact:
Björn Sjöstrand, CEO: +46 727-125 120, bjorn.sjostrand@scandinavianbiopharma.se

 

Scandinavian Biopharma
Scandinavian Biopharma is a Swedish research-based biotech company engaged in marketing and sales of vaccines, rapid infectious disease tests, antidotes, and immunoglobulins to the Nordic market. Research and development is mainly focused on development of a new oral ETEC vaccine. Travelers’ diarrhea is the leading cause of illness among international travelers to developing countries, and ETEC bacteria are the primary cause of this disease. About 80 million people travel from industrialized countries to high-risk areas in the developing world. Of these, 30 to 50 percent may experience at least one travelers’ diarrhea episode during their journey. ETEC is also a major cause of diarrheal disease among children living in endemic countries.

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