An obituary on DAV-132—authors’ viewpoint on the current limits of pivotal trials in clinical microbiome research

There is an urgent need for novel approaches to reduce the spread and clinical impact of infections with MDR bacteria. Da Volterra (Paris, France) is a biopharmaceutical company specializing in the development of microbiota-protective therapies. In 2010, they introduced DAV-132, an active charcoal preparation designed to protect the gut microbiota from antibiotic selection pressure, without affecting antibiotic pharmacokinetics, at the Superbugs and Superdrugs Conference in London, UK.¹ In 2016, Da Volterra joined the EU Innovative Medicines Initiative (IMI) to further develop this promising product in close cooperation with academic partners. Phase I and II trials were completed successfully, confirming the protective effect of DAV-132 on the human gut microbiota.^2,3 Consequently, a Phase III trial—MICROCARE—was planned and initiated. On 2 December 2022, however, the company Da Volterra was declared bankrupt. Given the significant clinical potential of DAV-132, this turn of events can be considered tragic. Could it have been avoided?

https://doi.org/10.1093/jac/dkad123