• DAV132 Phase 2 results are published in the Journal of Antimicrobial Chemotherapy
• DAV132 is well tolerated in patients and preserves intestinal microbiota diversity and C. difficile colonization resistance
• DAV132 sems effective for combatting the spread of pathogenic bacteria such as C. difficile and vancomycin-resistant enterococci
Paris (France), January 10, 2022 – Da Volterra, a late-stage biopharmaceutical company developing novel intestinal microbiome-protective therapies, announced today the publication of positive phase 2 clinical trial results in the Journal of Antimicrobial Chemotherapy (JAC). The data published demonstrate that, in hospitalized patients, DAV132 is well tolerated and able to preserve intestinal microbiota diversity and resistance to C. difficile colonization, without affecting antibiotic plasma levels.
The recently published article is entitled “An open randomized multicentre Phase 2 trial to assess the safety of DAV132 and its efficacy to protect gut microbiota diversity in hospitalized patients treated with fluoroquinolones”, and is authored by Maria J.G.T. VEHRESCHILD, Annie DUCHER, Thomas LOUIE, Oliver A. CORNELY, Celine FEGER, Aaron DANE, Marina VARASTET, Fabien VITRY, Jean de GUNZBURG, Antoine ANDREMONT, France MENTRÉ, and Mark H. WILCOX. The article can be accessed by following this link: https://academic.oup.com/jac/advance-article/doi/10.1093/jac/dkab474/6500724.
The Journal of Antimicrobial Chemotherapy is among the foremost international peer-reviewed journals in antimicrobial research. It is routinely read by representatives from academia, industry, and health services, as well as those who have influence on formulary decisions.
“We are very pleased with this publication in the JAC, allowing DAV132 to be better known as a viable therapeutic option among physicians and, we hope, more rapidly accessible to patients. I would like to personally thank all the authors who contributed to the publication of this paper which brings us a step closer to the launch of DAV132”, said Dr. Fabien Vitry, Chief Medical Officer at Da Volterra.
The phase 2 clinical trial, called SHIELD, was an open-label, randomized, multicenter trial comparing DAV132 with No-DAV132 in hospitalized patients at risk of Clostridioides difficile infection requiring a treatment with fluoroquinolones (FQ) of 5 to 21 days. The primary endpoint was the rate of adverse events independently adjudicated as related to DAV132 and/or fluoroquinolone administration. Plasma and fecal FQ concentrations, intestinal microbiota diversity, intestinal colonization with Clostridioides difficile, multidrug-resistant bacteria and yeasts, and ex-vivo resistance to Clostridioides difficile fecal colonization were assessed.
243 patients (median age, 71; 96% with chronic comorbidity) were included (No-DAV132, n=120; DAV132, n=123). DAV132- and FQ-related adverse events did not differ significantly: 18 (14.8%) versus 13 (10.8%) in DAV132 versus No-DAV132 patients (difference 3.9%; 95% CI, −4.7; 12.6). Day-4 FQ plasma levels were unaffected. DAV132 was associated with a
>98% reduction in fecal FQ levels (Day 4 to end-of-treatment, p
<0.001), less impaired microbiota diversity (Shannon index, p=0.003), increased ex-vivo resistance to Clostridioides difficile colonization (p=0.0003) and less frequent FQ-induced VRE acquisition (p=0.01).
“This study constitutes a compelling demonstration of the protection by DAV132 of the intestinal microbiota from dysbiosis caused by antibiotic treatments in patients. It shows that DAV132 could be a novel and an effective mean of combatting the spread of pathogenic bacteria such as C. difficile and vancomycin-resistant enterococci. It also reinforces our confidence in the use of DAV132 to prevent all the consequences of antibiotic-induced dysbiosis, including on immunity and survival in cancer patients. This publication is a considerable achievement for the team of Da Volterra that is performing high-quality research.”, declared Pr. Antoine Andremont, scientific founder of Da Volterra and President of its Scientific Committee.
The press release is available here.