ACE BioSci's Campylobacter vacc enters Ph I trial

Odense, Denmark-based drug developer ACE BioSciences AS says that its lead product, ACE393, the world's first commercial vaccine for diarrhea caused by Campylobacter infection, has entered Phase I clinical trials on schedule.

ACE393 is an injectable vaccine designed to combat the bacterium Campylobacter jejuni, one of the biggest causes of bacterial diarrheal infections in the developed world.

The vaccine's safety, tolerability and immunogenicity will be assessed in a two-stage, double-blind, randomized, placebo-controlled, 72-patient study. In stage one, subjects will receive a single intramuscular injection of the vaccine in escalating doses, starting at 25mcg, rising to 100mcg and finally 250mcg. In stage two, additional subjects will then receive two injections of a selected dose at a time interval determined by early results.