• World’s first phase 3 study of a microbiome protector, conducted as part of the European COMBACTE-NET program
• Consortium of European teams at the vanguard of microbiome research for patients with hematologic malignancies
• Objective to enroll 900 patients in approximately 80 centers worldwide
Paris (France) and Utrecht (The Netherlands), July 26, 2021 – Da Volterra, a late-stage biopharmaceutical company developing novel intestinal microbiome-protective therapies, and COMBACTE-NET, a public-private partnership co-funded by Innovative Medicines Initiative to stoke the pharmaceutical pipeline in Europe, announced today that the first patient had been randomized in the MICROCARE Phase 3 clinical trial. This follows the authorizations obtained from 7 regulatory authorities in Europe, including France, Germany, Spain and Denmark.
The MICROCARE trial is evaluating DAV132, a first-in-class and strongly innovative microbiome protector, and shall enroll 900 patients newly-diagnosed with acute myeloid leukemia or high-risk myelodysplastic syndrome treated with intensive chemotherapy in approximately 80 centers worldwide.
“We believe that protecting the microbiome of patients with acute myeloid leukemia is a clinically meaningful goal, as patients with disrupted microbiome have more life-threatening complications and a lower survival rate”, said Fabien Vitry, M.D., Chief Medical Officer of Da Volterra. “This study is a stepping stone for microbiome-oriented therapies and could pave the way to new treatment options for all patients with cancer.”
MICROCARE is a randomized, placebo-controlled, parallel-group trial. Its overarching objective is to demonstrate that DAV132 contributes to decreasing the occurrence of life-threatening complications and to reducing the mortality of patients with hematologic malignancies undergoing several cycles of chemotherapy.
“With all my team, we are glad to have recruited the first patient in MICROCARE.”, said Dr. Christine Robin, principal investigator at the Henri-Mondor Hospital (Creteil, France).
The primary endpoint will be the occurrence of Clostridioides difficile infection, a severe and life-threatening complication which is triggered by the disruption of the intestinal microbiome. The study will also assess the efficacy of DAV132 in protecting intestinal microbiome diversity, preventing intestinal colonization with potentially pathogenic bacteria, preventing bloodstream infections and improving Overall Survival.
“The MICROCARE trial offers an opportunity for change for patients and physicians alike, and it is also the proof that the clinical network of COMBACTE-NET, bolstered by IMI support, is up to the challenge of performing high-stake clinical studies.” commented Prof. Marc Bonten, M.D., Ph.D., Academic Coordinator of COMBACTE-NET. “All the partners of COMBACTE-NET are committed to making MICROCARE a real success for all stakeholders.”
The press release is available here.