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Da Volterra's DAV132 Shown As Promising Candidate for Preventing Severe C. Difficile Infections

Published: Tuesday, May 13, 2014
Last Updated: Tuesday, May 13, 2014
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The CL1001 clinical trial also demonstrated the adequate targeted delivery of DAV132 to the ileum and the colon and its adsorbing effects.

Da Volterra announces today very promising new results about DAV132 in the prevention of the side effects of antibiotics and the occurrence of severe Clostridium difficile infections. The Company presents two posters at ECCMID 2014 (the European Conference of Microbiology and Infectious Diseases) taking place in Barcelona on May 10-13, 2014.

With a novel and unique mechanism of action, DAV132 is a product candidate aiming at protecting the intestinal flora from the side effects of administered antibiotics, hence preventing Clostridium difficile infections. This pathogenic bacterium causes serious and potentially lethal gastro-intestinal infections. To this end, DAV132 captures the antibiotic residues in the digestive tract which are at the origin of the alterations of the intestinal flora, while maintaining the efficacy of the antibiotic treatment. As a consequence the flora disruption adverse effect is avoided.

• The CL1001 study, a phase I clinical trial performed in the spring 2013 at the Medicine University of Greifswald (Germany) with 18 healthy volunteers, showed the expected targeted delivery of DAV132. The results demonstrate that DAV132 effectively exerts its adsorbing effect in the ileum and the colon, whereas DAV132 does not interfere upstream with antibiotics in the small intestine. Antibiotic treatments given together with DAV132 would thus be optimized, DAV132 reducing the alterations of the flora and their consequences such as Clostridium difficile infections or the emergence of resistant bacteria.

• A preclinical study performed in the reference hamster model of Clostridium difficile infections evidenced the preventive effect of DAV132. Animals treated with moxifloxacin only (an antibiotic) showed 100% mortality (no survivor after 7 days) in the experiment. Interestingly, animals treated with moxifloxacin and DAV132 during 5 days are protected from the lethal impacts of Clostridium difficile. The protective effect of DAV132 is dose-dependent and a total protection is reached at the highest doses. This study in a predictive model of the disease illustrates the protective effects of DAV132, co-administered with an antibiotic treatment, against Clostridium difficile infections.

Florence Séjourné, CEO of Da Volterra, declared: "We are particularly proud to present these results to the scientific community, illustrating the very innovative and unique profile of DAV132. The control of Clostridium difficile infections and antibiotic resistance are major public health challenges. We look forward to advancing the development of DAV132, and are convinced that Da Volterra is well positioned to push forward its innovative product pipeline to meet these urgent medical needs."

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