MICROCARE Study Update

LAB-Net is involved in the MICROCARE trial, as the study’s central lab is based at the University of Antwerp. LAB-Net is providing investigational sites with sample collection and processing materials, has developed a Sample Collection and Management Manual, has trained the sites on sample collection and management procedures during the Investigator meetings and was involved in site selection.

As sample collection is up and running, samples are being shipped regularly from the local sites to the Central Laboratory where they are further processed.

Da Volterra is also proud to announce that two important milestones have been successfully reached recently with other studies:

• The publication of positive results from the SHIELD Phase 2 clinical trial evaluating DAV132 in patients in the Journal of Antimicrobial Chemotherapy. You can access it here
• The obtaining of compelling results in immuno-oncology showing that DAV132 is able to prevent antibiotic-induced loss of responsiveness to PD-1 blockade cancer therapy in a well-established animal model (results presented at the AACR Annual Meeting 2022)

About MICROCARE

Since July 2020, Da Volterra and COMBACTE-NET are collaborating in starting up the MICROCARE trial. MICROCARE is a multicentre, randomized, placebo-controlled, parallel-arm clinical trial performed across Europe and North America.

The trial aims to demonstrate the efficacy of DAV132, a microbiota-protective therapy in preventing the occurrence of Clostridioides difficile infection (CDI). The trial will enrol patients with newly diagnosed Acute Myeloid Leukaemia (AML) or high risk Myelodysplastic Syndrome treated with intensive chemotherapy.

The trial will determine whether the protection of the intestinal microbiota reduces the incidence of CDI, the colonization by multidrug-resistant bacteria, bacteraemia, acute graft-versus-host disease (GvHD), and improves the long-term survival of transplanted patients.