ACE BioSciences’ Lead Product, The World’s First Commercial Vaccine For Travellers’ Diarrhoea Caused By Campylobacter, Enters Clinical Trials On Schedule

ACE BioSciences A/S, the infectious diseases company is pleased to announce that its lead product, ACE393, the world’s first commercial vaccine for Travellers’ Diarrhoea (TD) 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 greatest causes of bacterial diarrhoeal infections in the developed world.

During the trial, the safety, tolerability and immunogenicity (ability to stimulate an immune response) of the vaccine will be assessed in a two Stage, double blind, randomised, placebo-controlled study. The company plans to recruit up to 72 healthy subjects and the trial will be undertaken at the Mediscis Phase I clinical unit in Poitiers, France. In Stage 1, subjects will receive a single intramuscular injection of the vaccine in escalating doses, starting at 25µg, rising to 100µg and finally 250µg. In Stage 2, additional subjects will then receive two injections of a selected dose at a time interval which will be determined by the results from Stage 1.

Dr Philippe Reboud, (Mediscis Phase I clinical unit) the study’s Principal Investigator commented “ACE393 is a very exciting vaccine candidate and the pre-clinical trial data, which revealed a benign side-effect profile, is particularly encouraging. ACE BioSciences has a unique approach to the identification and development of vaccine protein candidates that differentiates the company and underpins the considerable promise of ACE393. Campylobacter jejuni is responsible for considerable disruption and distress to business and holiday travellers around the globe and I look forward to evaluating a product which will address a genuine unmet medical need.”

Ms Ingelise Saunders, ACE BioSciences’ CEO commented “This is excellent news for ACE BioSciences and an important milestone in the company’s evolution. The initiation of this trial follows the completion of pre-clinical research in just 21 months from selection of lead candidate, which is a remarkable achievement for a protein drug. The Phase I trial is scheduled for completion early in 2007 and if all goes to plan, first market launch of ACE393 should take place in 2010.”

“TD is the most frequent health problem in travellers from industrialized countries visiting developing countries and we estimate that the annual global market for a Campylobacter vaccine is worth € 350 million. We aim to claim substantial market share by providing a vaccine that delivers good protection and low side effect risk. Furthermore, as part of our collaboration with Nordic Vaccine A/S we will work on patch and oral delivery technologies, which will be very beneficial in terms of patient acceptability and delivery convenience.”