MICROCARE Continues Study Preparations

Latest developments

The MICROCARE study team is working on setting up the study in Europe. In a press release Da Volterra announced it received approval to start enrolling patients in the Phase 3 MICROCARE, the clinical trial evaluating DAV132, its first-in-class microbiota protector. The biopharmaceutical company received its first approvals from regulatory authorities in France and Hungary.

In parallel the team is working hard to finalize sites selection. To date, 57 sites have been selected out of the 79 sites that were chosen for a Site Selection visit. The site selection was conducted in Austria, Belgium, Croatia, Czech Republic, Denmark, France, Germany, Hungary, Israel, Italy, Poland, Slovakia, Spain and UK. Clinical site selection is progressing in the United States as well.

The COMBACTE studies

MICROCARE will be a Phase 3, multicenter, 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) Onco-hematological sites are selected for this trial, which have to work to the inclusion target of 900 patients.

COMBACTE-NET’s ANTICIPATE was an observational study conducted to prepare the design of the interventional study with DAV132. ANTICIPATE confirmed that low gut microbiota diversity is a factor that favors the development of CDI; the low incidence of CDI conducted to look for and select another target population to perform the interventional study.

PREVENTING CDI

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. Extensive preclinical studies, including in vivo models on survival in hamsters with CDI showed that the product was highly successful in preventing antibiotic-induced CDI. The results from randomized clinical trials conducted in healthy volunteers and in patients showed that DAV132 adsorbed residues of antibiotics in the colon and protected the intestinal microbiota from the dysbiosis induced by antibiotics while preserving their bioavailability. DAV132 was safely used in hospitalized patients with concomitant drugs and could be administered in patients taking narrow therapeutic index drugs.