Date: 2014-05-09
Type of information:
phase: 1
Announcement: presentation of results at the ECCMID conference
Company: Da Volterra (France)
Product: DAV132
Action
mechanism: DAV132 is a product candidate aiming at protecting the intestinal flora from the side effects of administered antibiotics, hence preventing Clostridium difficile infections. DAV132 is a non specific adsorbent which can irreversibly capture antibiotics in the late ileum, caecum and colon before they could alter significantly the microbiota. It is encapsulated in a specific drug delivery system (specific coating) patented by Da Volterra that allows a precise delivery to the lower gastro-intestinal tract in order to avoid all interactions with drug absorption that occurs in the small intestine.
Disease: Clostridium difficile infections
Therapeutic area: Infectious diseases
Country:
Trial details:
Latest
news: * On May 9th, 2014, Da Volterra, a leading biopharmaceutical company in the field of bacterial resistance, announced 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.
- 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. (DAV132, developed to prevent side effects of antibiotics in the gut flora: Results of a pilot cross-over study in healthy volunteers. A. Ducher, C. Modess, W. Weitschies, W. Siegmund, J. Dressman, V. Augustin, C. Feger, A. Andremont and J. de Gunzburg)
- 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. (DAV132, an oral adsorbent-based product, exerts a dose-dependent protection of hamsters against moxifloxacin-induced Clostridium difficile lethal infection. C. Miossec, S. Sayah-Jeanne, V. Augustin, E. Chachaty, W. Weiss, T. Murphy, M. Pulse, A. Andremont, and Jean de Gunzburg)
