• FDA Fast Track Designation has been granted to DAV132 for the prevention of Clostridioides difficile infection, a life-threatening condition with persistent unmet medical need, especially in cancer patients
• DAV132 is a first-in-class microbiome protector with positive Phase 2 data and a Phase 3 being launched in patients with hematologic malignancies
Paris (France), April 6th, 2021 – Da Volterra, a late-stage biopharmaceutical company developing new intestinal microbiome-protective therapies, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for its first-in-class microbiome protector, DAV132, in the prevention of Clostridioides difficile infection (CDI) in patients at high risk of CDI. Da Volterra is about to launch a Phase 3 clinical trial (called MICROCARE) evaluating DAV132 in patients with hematologic malignancies.
The FDA Fast Track Designation intends to facilitate the development and review of drug candidates for treating or preventing serious conditions that demonstrate the potential to address unmet medical needs. The Fast Track Designation confers several advantages including more frequent interactions with the FDA to discuss development plans and access to Accelerated Approval and Priority Review. This expedited program will allow Da Volterra to make rapid progress in bringing DAV132 to market and to patients sooner.
“By awarding Fast Track Designation for DAV132, the FDA has recognized its high value for patients in protecting the gut microbiome, notably to prevent C. difficile infection, which can be life-threatening, particularly in cancer patients. It is a major acknowledgement as we are about to launch a Phase 3 clinical study for cancer patients who currently have no good preventive option”, said Florence Séjourné, Da Volterra’s Chief Executive Officer.
“We are pleased to have received Fast Track designation from the FDA and look forward to working closely with them to expedite the clinical development of DAV132”, said Fabien Vitry, Da Volterra’s Chief Medical Officer.
Press release available here