COMBACTE-NET partner Da Volterra can move forward with phase 3 trial of an innovative product used to protect the microbiome of patients from antibiotic-induced disruption
The microbiome of cancer patients is constantly assaulted by numerous prescribed drugs, in particular life-saving antibiotics. But this comes at a price; the microbiome of these patients is generally strongly disrupted and patients face a number of deleterious consequences such as higher risk of picking up antibiotic-resistant and pathogenic bacteria like Clostridioides difficile, lower efficacy of anti-cancer treatments and even potentially lower survival due to interference with the immune system. There is now hope for change.
In a world first, the French biotech Da Volterra, a partner in the COMBACTE-NET project, has been granted authorisation to proceed to a phase 3 trial to get evidence on the efficacy and safety of its microbiome protector product, DAV132, in patients with hematologic malignancies (cancers of the blood, bone marrow and lymph nodes). The product, they claim, will protect the microbiome of these patients in spite of massive antibiotic use.
The MICROCARE study will enrol 900 patients mainly in Europe and the USA. The objective is to show that DAV132 contributes to decreasing the occurrence of life-threatening complications of hematologic malignancies in people who are undergoing chemotherapy.
“Conducting the MICROCARE study as part of the COMBACTE-NET consortium is a tremendous opportunity as the team comprises top-notch European experts and several high-value supporting facilities all over Europe,” says Florence Séjourné, Chief Executive Officer of Da Volterra. “COMBACTE-NET leverages the energy put by the Da Volterra team, giving us a strategic edge and ultimately speeding up patients’ access to this breakthrough innovation.”
The first authorisations have been granted by three regulatory authorities in Europe: the French National Agency for Medicines and Health Products Safety (ANSM), the Hungarian National Institute of Pharmacy and Nutrition (OGYÉI) and the Czech State Institute for Drug Control (SÚKL). The primary endpoint of the trial 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 colonisation with potentially pathogenic bacteria, preventing bloodstream infections and improving overall survival.
The study is a major milestone. It is a testament to the capacity of the quality clinical and laboratory research network set up by COMBACTE-NET and its ability to successfully conduct the first-ever phase 3 study of the project, thus facilitating market access of novel products to combat life-threatening conditions and antimicrobial resistance (AMR).