Da Volterra Announces Publication of Full Results from Clinical Trial of DAV132 to Prevent the Disruption of the Microbiome b...
January 16 2018 - 6:00AM
Business Wire
- 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, a leading biopharmaceutical company in the
field of anti-infectives and microbiome protection, 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.
Annie Ducher MD, Chief Medical Officer of Da Volterra, declared:
“This clinical study is indicative of the potential of DAV132 to
become one of the first preventative solutions to protect the
intestinal microbiome and further avoid the detrimental
consequences of antibiotic treatments, such as Clostridium
difficile infections, for patients. We look forward to advancing
the development of DAV132 in a pivotal patient study in 2018.”
Jean de Gunzburg PhD, Chief Scientific Officer of Da Volterra,
added: “This study constitutes the first scientific demonstration
of the protection of the intestinal microbiome from dysbiosis
caused by a fluoroquinolone antibiotic treatment; our data suggests
that this effect should be extendable to many different antibiotics
from several therapeutic classes. The metagenomics analysis is
outstanding and thoroughly convincing that DAV132 is highly
effective at protecting the commensal bacteria in the
intestines.”
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.
***
About DAV132:With a novel and unique mechanism of action,
DAV132 is a product candidate aiming to protect the intestinal
microbiome from the side effects of antibiotics, hence preventing
the onset of C. difficile infections. DAV132 is an adsorbent with a
proprietary coating with colon targeted delivery. DAV132 has been
tested in four Phase 1 clinical studies with no adverse safety
events. DAV132 is currently entering a Phase 2 clinical trial.
About Da Volterra:Da Volterra is a biopharmaceutical
company based in France that develops new strategies aimed at
protecting the intestinal microbiome from the deleterious effects
of antibiotics, and preventing multi-resistant and life-threatening
infections. Da Volterra’s innovative approaches promise a
substantial medical progress to combat deadly pathogens.
http://www.davolterra.com
View source
version on businesswire.com: http://www.businesswire.com/news/home/20180116005398/en/
Da VolterraFlorence Séjourné, Tel: +33 1 58 39 32
20CEOEmail: press@davolterra.com