The extension of the clinical trial in Canada will add 5 new sites to those already active in the United States and accelerate patient enrolment for the second part of the trial
Dr. Thomas Louie, Professor of Microbiology and Infectious Diseases at the University of Calgary (Canada) and a world expert on Clostridioides difficile, will be the medical lead for the study in Canada
DEINOVE (Euronext Growth Paris, ALDEI), a French biotech company, pioneer in the exploration and exploitation of bacterial biodiversity to address the urgent, global challenge of antibiotic resistance, announced today the extension of its clinical trial to Canada, approved by the Canadian Health authority, with the opening of 5 new sites, complementing those already opened in the United States. This second country will accelerate patient enrollment in this Phase II clinical trial of DNV3837 in Clostridioides difficile infections.
This announcement follows the review of the data from the first part of the trial by the independent Data Safety Monitoring Board (DSMB), which gave a positive opinion for the continuation of the trial (see press release of January 6, 2022).
The second part of the study will be conducted in an open-label manner. Thus, all 40 patients who will be included in the trial will receive DNV3837. As a reminder, the second part of the trial has been optimized with a reduction in the dose and duration of intravenous administration to 6 hours per day during the 10-day treatment period. This modification simplifies the management of the trial for the investigating physicians and their teams.
Dr. Thomas Louie, Professor of Microbiology and Infectious Diseases at the University of Calgary (Canada) and a world expert on Clostridioides difficile, will lead and report on the trial in Canada. He said: “I am delighted to join this trial to evaluate DNV3837, which could be an important advance in the management of patients with Clostridioides difficile infection, in particular severely affected patients with bowel dysmotility where orally administered antimicrobials may have difficulty reaching the active site of infection.”
Alexis Rideau, CEO of DEINOVE, concluded “The extension of our trial into Canada is a major step forward for DEINOVE and provides new hope for Canadian patients. We are proud to work with leading specialists, notably Dr. Thomas Louie, a world expert in the development of innovative therapeutic solutions for Clostridioides difficile infections.”