Da Volterra, a biotech company developing products in the antibacterial field, has announced results in a human clinical trial for DAV132, a product said to prevent life-treating bacterial infections during antibiotic treatments.

According to Da Volterra, many orally administered antibiotics are only partially absorbed in the upper intestinal tract upon ingestion, and much of the administered drug passes into the lower intestinal tract.  These drugs can then wreak havoc on the natural intestinal microbiota of patients and allow several potentially harmful bacterial strains to proliferate.  In particular, the bacterium Clostridium difficile proliferates and can cause potentially life-threatening infections.  DAV132 is co-administered with antibiotics and functions as a non-specific adsorbent that can capture antibiotics in the lower intestinal tract before they can signficantly alter the patient’s microbiota.  However, DAV132 is said to be inactive in the upper intestinal tract and does not interfere with the drug’s therapeutic efficacy.  The function of DAV132 is demonstrated in the video here.

DAV132 was co-administered with moxifloxacin in a randomized controlled clinical trial performed in 44 healthy human volunteers.  According to DaVolterra, Phase I study results show that DAV132 reduced the exposure of intestiinal microbiota by 99% and maintained 97.8% of the microbiome’s genetic richness while protecting 93% of bacterial species.   This sharply contrasts to a gene richness of 54% and 39% of bacterial species protected when moxifloxacin was administered alone.  Dr. Jean de Gunzburg of De Volterra commented on the results of the study in a recent publication of the Journal of Infectious Diseases:

DAV132 was highly effective to protect the gut microbiome of moxafloxacin-treated healthy volunteers and may constitute a clinical breakthrough by preventing adverse health consequences of a wide range of antibiotic treatments.

According to USPTO public records, Da Volterra is a listed assignee of, for example, U.S. Patent Nos. 8,388,984 and 8,106,000.