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US regulator to expedite review of gut microbiome protector product from COMBACTE partner

The US FDA grants ‘fast track designation’ to Da Volterra’s DAV132 for the prevention of Clostridioides difficile infection 

Image by Berke via Shutterstock
Image by Berke via Shutterstock


DAV132 is a first-in-class microbiome protector designed to inactivate antibiotics that are circulating in the colon and disrupting the gut microbiome. It is destined for use in patients for whom microbiome disruption can be life-threatening, such as those with cancer. The product was developed by Da Volterra, a biopharmaceutical SME that develops new intestinal microbiome-protective therapies. The company is about to launch an international phase 3 clinical trial (called MICROCARE) to evaluate DAV132 in patients with hematologic malignancies, as part of the IMI COMBACTE-NET project.

In COMBACTE-NET, Da Volterra is working in close collaboration with the project’s academic partners in initiating the study, with the support of CLIN-NET, LAB-NET and STAT-NET networks developed within the project. MICROCARE is the first phase 3 clinical study conducted within the COMBACTE-NET project. It will demonstrate the capacity of the networks to successfully conduct studies that test novel therapeutic strategies, thus speeding up access to new drugs on the market to combat AMR.

The FDA Fast Track Designation is intended to speed up the review of drug candidates for treating or preventing serious conditions. Earlier this year, three regulatory authorities in Europe granted authorisation for the MICROCARE study to go ahead. The study will assess the efficacy of DAV132 in protecting intestinal microbiome diversity, preventing intestinal colonisation with potentially pathogenic bacteria, preventing bloodstream infections and improving overall survival.

This study will build on the results of ANTICIPATE, a multi-centre, prospective, observational study conducted within COMBACTE-NET to identify microbial factors predictive of CDI. For more information on the results of ANTICIPATE read this paper in Nature.


Regulators clear study of gut microbiome ‘protector’ in cancer patients

Focus: Antimicrobial resistance



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