27/01/2021 combacte-net News Item

Site Selection in Full Swing in MICROCARE

The clinical site selection process for COMBACTE-NET's MICROCARE study started on July 2nd with initial involvement of the CLIN-Net and LAB-Net teams who prepared the feasibility questionnaires, contacted the sites and analyzed the questionnaires answers.

A site selection board, consisting of members from the academic partners and the EFPIA lead, has been set up and meets regularly.

The clinical CRO then joined the process to follow-up with Site Qualification Visits with their monitors. To date, 42 sites have been selected in Belgium, Czech Republic, Denmark, France, Germany, Hungary, Italy, Poland and Spain. The process is still ongoing, delayed in some countries due to the COVID-19 crisis. Meanwhile, Da Volterra is also selecting clinical sites in the US.

Regulatory submissions started on 04-Dec-2020 in France. The first Site Initiation Visit is planned for mid-Feb-21.

About MICROCARE

MICROCARE is a Phase 3 study that aims to demonstrate the efficacy of DAV132, a microbiota-protective therapy developed by Da Volterra, in preventing the occurrence of Clostridioides difficile infection (CDI) in patients with newly diagnosed Acute Myeloid Leukemia (AML) or high risk Myelodysplatic Syndrome treated with intensive chemotherapy.

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

During AML treatment, most patients receive several courses of antibiotics for febrile neutropenia (prophylaxis or empirical treatment) or for suspected or documented bacterial infections. The incidence of CDI, one of the clinical manifestations of microbiota disruption (also called dysbiosis), is high in patients. A study by Amit et al. in 2015 demonstrated that CDI is a predictor of Gram-negative blood stream infections, one of the major complications in AML patients. Furthermore, intestinal dysbiosis, including the decrease in intestinal microbial diversity, is associated with more severe acute GvHD in patients undergoing allo-HSCT.

DAV132 is a colon-targeted adsorbent that binds small molecules like antibiotics and is released in the colon thanks to a special coating.

When administered concomitantly with antibiotics, it protects the intestinal microbiota from their damaging effects. The main clinical target DAV132 is developed for multiple indications including prevention of CDI.