Deinove SA announced 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. 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. More than 40% of hospitalized patients with Clostridioides difficile infection (CDI) have been classified as severe disease associated with higher morbidity and mortality1.

The Centers for Disease Control and Prevention (CDC) identifies CDI as one of the leading causes of hospital-acquired infections, ahead of even MRSA2 infections. In the United States, it is estimated that CDI causes nearly half a million disease cases each year, and approximately 29,300 deaths3. This condition is not limited to the United States and recent studies4 show that the incidence of this type of infection is greatly underestimated in other parts of the world, such as Europe and Asia.

To date, there is no proven therapeutic solution for CDI patients with severe vomiting, ileus and toxic megacolon. The oral route being compromised, the available treatments, which are mostly oral, have difficulty reaching the intestine because of the patient's pathological condition (reduced gastrointestinal motility, intubation, intestinal perforation, etc.), and the few antibiotics that could be administered intravenously do not cross the gastrointestinal barrier and therefore do not reach the infection site. DNV3837 – a prodrug5 of the DNV3681 molecule (also known as MCB3681) – is a narrow-spectrum, hybrid oxazolidinone-quinolone synthetic antibiotic targeting only Gram-positive bacteria.

It is developed as a highly active first-line treatment targeting C. diff. It has demonstrated significant activity and superiority to reference treatments against isolates of C. diff., regardless of their virulence (including the hyper virulent BI/NAP1/027 strain). DNV3837 is an intravenous antibiotic that, when converted to its active form DNV3681, crosses the gastrointestinal barrier and accumulates in the intestinal lumen, allowing it to precisely target the infection site.

Several Phase I trials (on approximately a hundred healthy volunteers) have shown a high concentration of the antibiotic in stools, a strong marker of its presence in the intestine. It has also demonstrated its ability to eliminate Clostridioides bacteria without affecting the gut microbiota. FDA granted the DNV3837 drug with Qualified Infectious Disease Product (QIDP) designation and Fast Track status.