Case Study

Da Volterra – DAV132

Sub category of Industry Biotechs, R&D Pharma
Category of commitment Research & Science
Which product(s) Alternative technologies
Key focus Late-stage R&D
Key partners of the program Governments
Geographic focus Global

Health needs

The usage of large-spectrum antibiotics prescribed to treat infections, can generate consequences on patients health linked to the deleterious effects of those antibiotics on the microbiota. It is well demonstrated that the natural excretion of antibiotics by the colon can indeed trigger the development of resistant bacteria and also the abnormal growth of otherwise small bacterial population like C.difficile. Broadly wiping out the majority of bacterial species in the intestine can make patients vulnerable to more serious infections.

Initiative’s objective

DAV132 is a product based on the local delivery, at the ileo-ceacal junction, of a powerful adsorbent, which has been proven effective in solving this problem by drastically decreasing antibiotic exposure in the colon. It thus allows antibiotics to kill pathogenic microbes via their systemic action, while sparing those that are important to gut health.

Initiative’s description

Da Volterra is a biopharmaceutical company based in Paris which develops innovative solutions for the prevention and treatment of serious infections, for which there is a growing medical need. With antibiotic resistance and hospital-acquired infections threatening medical practice, Da Volterra’s innovative approaches promise substantial medical progress in line with the expectations of healthcare professionals. The company’s most advanced product, DAV132, is being developed to prevent Clostridium difficile infections and the emergence of resistant bacteria in at-risk patients by protecting intestinal flora from antibiotic-induced disruption. The product has already been tested in four clinical trials and has demonstrated the proof of concept of protection of intestinal microbiota from antibiotic dysbiosis.

Da Volterra has raised 25M€ up to now to pursue the development of the program.

One of those studies (DAV132-CL-1002) was partially sponsored by the European Union Seventh Framework under grant agreement n° 282004, EvoTAR, as well as BPIFrance under the NOSOBIO collaborative program.

Impact

284 Human volunteers have been administered DAV132 up to now in 4 clinical studies.

Lessons for success

DAV 132 is a preventive approach to tackle infections and the development of AMR. Apart from a direct medical benefit for patients, it should have a collective ecological and societal benefit as it would decrease the selection and dissemination of resistant bacteria.
Up to now, both regulatory partner and payers do not value such a collective benefit.
Such ecological and societal benefits of alternative strategies represent a novel paradigm in addressing healthcare products in the field of AMR. They should therefore be evaluated and valued by regulators and payers, not only for their capacity to treat infectious diseases, but in the light of their potential contribution to better control infection risks and resistant bacteria dissemination.