09/02/2021 combacte-net News Item

Press Release: Da Volterra Receives first Authorizations from Regulatory Authorities in EU Countries to Initiate its Phase 3 Clinical Trial Evaluating the Microbiome Protector DAV132 in Patients with Hematologic Malignancies

Paris (France), February 3rd, 2021 – Da Volterra, a clinical-stage biopharmaceutical company developing innovative products to prevent the life-threatening effects antibiotics have on the gut microbiome of cancer patients, announced today that it received approval to start enrolling patients in a Phase 3 clinical trial evaluating DAV132, its first-in-class microbiota protector. Authorizations by two regulatory authorities in Europe, the French National Agency for Medicines and Health Products Safety (ANSM) and the Hungarian National Institute of Pharmacy and Nutrition (OGYÉI), represent an important milestone for Da Volterra. The trial, named MICROCARE, is conducted in collaboration with partners of the COMBACTE-NET consortium and is co-funded by the Innovative Medicines Initiative (IMI).

The MICROCARE study will enroll 900 patients from clinical sites mainly in Europe and in the USA. The European Coordinator is Professor Maria J.G.T. Vehreschild, MD, Head of Infectious Diseases at Frankfurt University Hospital. The overarching objective of the trial is to demonstrate that DAV132 contributes to decrease the occurrence of life-threatening complications and to reduce the mortality of patients with hematologic malignancies undergoing several cycles of chemotherapies. The primary endpoint will be the occurrence of Clostridioides difficile infection, a severe and life-threatening comorbidity. 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 use of DAV132 in patients with Acute Myeloid Leukemia and Myelodysplastic Syndrome patients treated with intensive chemotherapy is supported by a strong scientific and medical rationale and offers a novel and differentiated strategy with the potential to bring patients multiple benefits linked to microbiome protection, including better survival.” declared Prof. Maria J.G.T. Vehreschild.

To date, 496 human subjects have been exposed to DAV132 in six Phase 1 and one Phase 2 clinical studies with no safety risk observed. The recent success of the Phase 2 SHIELD study showed that DAV132 was safe for use in hospitalized elderly patients with several comorbidities and taking concomitant medications. It also demonstrated that DAV132 was able to protect the intestinal microbiome from antibiotic damage. “It is an historic moment for DAV132 and the beginning of a new era for hemato-oncology patients: now, for the first time, we will be able to protect the microbiome of these patients in spite of their massive antibiotic use. At Da Volterra, all the team is very proud of being again in the vanguard of research for the benefit of patients.” commented Dr. Fabien Vitry, Chief Medical Officer of Da Volterra.

Da Volterra Receives first Authorizations from Regulatory Authorities in EU Countries to Initiate its Phase 3 Clinical Trial Evaluating the Microbiome Protector DAV132 in Patients with Hematologic Malignancies