Results of Clinical Trial for DAV132 Published in JID

16 January 2018

Da Volterra announces the publication of full results of a clinical trial in humans for DAV132, a product to protect the microbiota from disruption by antibiotics and prevent C. difficile infections.

• The clinical study was the first worldwide demonstrating that an inventive colon-targeted adsorbent can prevent the disruption of the microbiome when antibiotics are prescribed.
• DAV132 is a first-in-class product to protect the microbiome during antibiotic treatments and prevent Clostridium difficile infections.

 

Da Volterra announced today the publication of groundbreaking results in the Journal of Infectious Diseases from a clinical study of DAV132 for the protection of intestinal microbiota from disruption caused by antibiotics. In an era of strong antibiotic use, this clinical trial yielded highly encouraging data showing that it is possible to use antibiotics and safely avoid their deleterious effects on the gut microbiome.

In a randomized, controlled clinical trial performed in 44 healthy human volunteers, DAV132 was used in association with moxifloxacin, a widely used fluoroquinolone antibiotic. It was demonstrated that DAV132 is able to effectively capture residual antibiotics in the colon and reduce their concentration to very low levels. DAV132 reduced exposure of the intestinal microbiota to moxifloxacin by 99%. Meanwhile the plasma concentration of the antibiotic was essentially unaffected by the co-administration DAV132, meaning that its therapeutic efficacy will be maintained.

The ability of DAV132 to protect the intestinal microbiome was explored by identifying changes in bacterial gene richness as well as a detailed statistical analysis of the evolution of bacterial species throughout the study. In volunteers who received moxifloxacin alone, gene richness was drastically diminished to 54.6% of baseline after antibiotic treatment and failed to return to baseline even one month after treatment; 39% of bacterial species identified in the intestinal microbiota were affected. The co-administration of DAV132 with moxifloxacin largely protected the intestinal microbiome from disruption (97.8% of baseline for bacterial gene richness, and 93% of bacterial species protected).

The primary endpoints for the study were fully achieved and DAV132 showed an excellent tolerability profile.

The results are available under the reference: Gunzburg et al. Protection of the human gut microbiome from antibiotics. The Journal of Infectious Diseases, jix604, https://doi.org/10.1093/infdis/jix604.

For more information please see our press release.

Our press release in French may also be found here.