Groundbreaking results seen in microbiome trial


Pharma IQ News
01/23/2018

In an era of strong antibiotic use, a clinical trial has yielded highly world first, positive results on how to protect gut microbiome from damage. 

French biopharmaceutical company Da Volterra announced the publication of encouraging clinical trial data showing it is possible to use antibiotics and safely thwart their harmful effect on the gut microbiome.

How to antibiotics damage microbiome?

Millions of lives have been saved through the administration of antibiotics, however recent findings have shown that their use has lasting changes on a patient’s microbiome.

Antibiotic resistance and healthcare-acquired infections such as Clostridium difficile infections, represent an ever-growing public health challenge worldwide.

Annie Ducher MD, Chief Medical Officer of Da Volterra, declared: “This clinical study, conducted at the Hospital Bichat CIC in partnership with the IAME laboratory, 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.

Antibiotics microbiome damage

DAV 132

The product candidate in question - DAV132 – aims to protect the intestinal microbiome from the side effects of antibiotics. It has been tested in four Phase 1 healthy human volunteer clinical studies with no adverse safety events.

The results of the study demonstrated that the inventive colon-targeted adsorbent DAV132 is able to effectively capture residual antibiotics in the colon and reduce their concentration to very low levels. Results showed 97.8 % protection of gene richness

The candidate is now entering a Phase 2 clinical trial.

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

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 we have conducted in partnership with the MetaGenoPolis team is outstanding and thoroughly convincing that DAV132 is highly effective at protecting the commensal bacteria in the intestines.”