Danish drugmaker ACE BioSciences SA says it has initiated patient dosing in a challenge trial of its Campylobacter vaccine, ACE393, which is being developed to treat travellers' diarrhea. The study, which is being conducted in collaboration with the US Naval Medical Research Center, follows Food and Drug Administration acceptance of an Investigational New Drug application.
ACE explained that the program is designed to establish a workable model of the disease state, including to identify the most appropriate "dose" of bacteria to use in future assessments of the vaccine. The firm added that the trial will utilize strains of Campylobacter that have been shown to lack the features responsible for the development of Guillian Barre Syndrome, a post-infection polyneuropathy that is linked to the illness.
The company went on to say that the dose of bacteria provided will be gradually increased until 75% of the participants have a well-defined level of disease, with results anticipated in the second half of the year.
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