New EFPIA Lead COMBACTE-NET
The biotech company Da Volterra has recently been designated as the new EFPIA lead of the COMBACTE-NET project, replacing AstraZeneca. Da Volterra joined the COMBACTE consortium in 2016 to collaborate in the ANTICIPATE study and, since then, is preparing a phase 3 study that aims to evaluate the efficacy of DAV132 as a Microbiota Protective Treatment.
While AstraZeneca is stepping down from the role of EFPIA lead, it will continue to remain a partner within COMBACTE.
A Great Opportunity
“We are happy to assume the responsibility of co-leading the COMBACTE consortium with the University Medical Center of Utrecht, it is a great opportunity for a biotech like us. We would like to thank Hasan Jafri’s team at AstraZeneca for their hard work up until now, in steering the development of such an ambitious program. We will do our best to keep up the good work. We are excited to operate such a big program, and work with partners and existing governing bodies to lead the project to a successful end.”
About Da Volterra
Da Volterra is a French biotech company that develops innovative products to protect the intestinal microbiota from the deleterious effects of antibiotics to respond to growing unmet medical needs in the fields of infectiology, gastroenterology, oncology and hemato-oncology.
Da Volterra’s most advanced product, DAV132, is a first-in-class oral phase 3 ready-product designed to capture antibiotic residues in the gut and abrogate their harmful impact on the microbiota. DAV132 is developed in several indications associated to the preservation of a healthy microbiota, including the prevention of Clostridioides difficile infections and resistant bacteria colonization in the gut of patients at risk, starting with patients with hematologic malignancies.
About ANTICIPATE
ANTICIPATE – AssessmeNT of the Incidence of C .difficile Infections in hospitalized Patients on Antibiotic TrEatment – is an observational, epidemiological study involving hospitalized patients undergoing oral or intravenous broad-spectrum antibiotics treatments. The study aims to determine the incidence of C. difficile infections and to better prevent this severe pathology.
C. difficile infections spread in the environment via infected individuals with intestinal flora disrupted by antibiotic treatment. During the last decade the number of infections has increased rapidly, leading to growing concern across the world. Centers for disease control and prevention (CDCs) estimated that C. difficile causes 500,000 infections and 29,000 deaths each year in the United States alone. At a cost of over $4 billion. In Europe, the rise of C. difficile is just as worrying, costing society an estimated €3 billion a year.
EMA recommends Marketing Authorization for ATM-AVI
Pfizer Receives Positive CHMP Opinion for its Novel Antibiotic Combination for the Treatment of Patients with Multidrug-Resistant Infections and Limited Treatment Options
COMBACTE is proud to announce a significant milestone achieved in COMBACTE-CARE. The European Medicines Agency (EMA) has recommended granting a market...