Enrolment of first patient in Phase II trial testing DNV3837 in Clostridioides difficile infections

Enrolment of first patient in Phase II trial
testing DNV3837 in Clostridioides difficile infections

• The Phase II clinical trial aims to evaluate the efficacy, safety and pharmacokinetics of DNV3837 in patients with Clostridioides difficile gastrointestinal infection (CDI).
• The trial will be conducted mainly in 15 centers in the United States, in two successive stages:
  • a cohort of 10 patients with moderate to severe CDI treated with DNV3837,
  • a randomized cohort study testing DNV3837 against standard of care in 30 patients with severe CDI.
• The final results of this trial are expected by the end of 2020.
• DEINOVE is the only French player to conduct a clinical trial with an antibiotic.
• On 17 January, the WHO warned about the extreme lack of new antibiotics and the threat posed by the antibiotic resistance.

DEINOVE (Euronext Growth Paris: ALDEI), a French biotech company that uses a disruptive approach to develop innovative antibiotics and bio-based active ingredients for cosmetics, announced the inclusion of the first patient in the Phase II trial testing DNV3837.

DNV3837 targets the treatment of Clostridioides difficile infections (CDI), a disease classified as a priority by the WHO and one of the global leading causes of healthcare-related infections¹.

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. DNV3837 has demonstrated a promising efficacy profile and acceptable tolerance in Phase I trials (on healthy volunteers). It has also demonstrated its ability to eliminate Clostridioides bacteria without affecting the gut microbiota. It has been granted Fast Track status and QIDP designation².

The Phase II trial aims to evaluate the efficacy of DNV3837 in pathological conditions (through monitoring of symptoms, stool analysis, etc.), as well as to consolidate the safety and pharmacokinetic data of the antibiotic candidate.

This trial is concentrated in the United States. It will take place in two stages:

• In the first phase, involving 5 centers, a cohort of 10 patients with moderate to severe CDI will be treated with DNV3837. At the end of this phase, the DSMB³  will review the interim results.
• The second phase will involve 30 patients with severe CDI and will be carried out in 15 investigation centers. This will be an open-label randomized trial testing DNV3837 (in 2/3 of patients) against an approved standard of care⁴ (1/3 of patients) for comparison purposes.

The results of this clinical trial should be available by the end of 2020.