In 2021, Da Volterra launched MICROCARE: a pivotal Phase 3 clinical trial to demonstrate the clinical benefits of DAV132 in 900 patients with hematologic malignancies (specifically acute myeloid leukaemia or high-risk myelodysplastic syndrome) who are at high risk of developing infections and other life-threatening complications.
MICROCARE is a randomised, controlled, parallel-group trial.
The primary endpoint is the occurrence of Clostridioides difficile infection, a serious and sometimes fatal complication caused by disruption of the microbiome. The study will also evaluate the efficacy of DAV132 in protecting the diversity of the microbiome, preventing colonisation of the gut by pathogenic bacteria, preventing bacteremia and improving overall patient survival.
A first patient has been enrolled in July 2021 in Europe.
If the results are conclusive, DAV132 could be commercialized as early as 2025 and thus become the first microbiome protector marketed in the world.