Enrolment of first patient in Phase II trial testing DNV3837 in Clostridioides difficile infections - Seite 2
"The start of this Phase II clinical trial is a significant step forward for DEINOVE and a great hope for patients. We are very proud to provide a potential solution to this unmet medical need and, to this end, work with the best American specialists in this area. The investigation centers are very committed to conducting this trial which, in the event of positive results, will be an important milestone towards the registration of DNV3837," said Dr Georges Gaudriault, Scientific Director of DEINOVE.
This announcement echoes warnings issued by the WHO about the lack of antibiotics renewal.
Dr Tedros Adhanom Ghebreyesus, Director-General of WHO, declared last January 17 « Never has the threat of antimicrobial resistance been more immediate and the need for solutions more
urgent ».
https://www.who.int/news-room/detail/17-01-2020-lack-of-new-antibiotic ...
ABOUT CLOSTRIDIOIDES DIFFICILE INFECTIONS
40% of patients suffering a Clostridioides difficile infection (CDI) have severe forms, with mortality rates as high as 50%. Over the past 20 years, CDIs tended to increase significantly in incidence and severity, particularly due to the development of new hypervirulent strains and the high risk of recurrence. The US Center for Disease Control and Prevention (CDC) recently identified CDIs as one of the leading causes of healthcare-associated infections before Staphylococcus aureus (MRSA5) infections. In 2017, in the United States, there were an estimated 223,900 cases in hospitalized patients and 12,800 deaths6. This disease does not affect the United States only, recent studies7 show that the incidence of this type of infection is vastly underestimated in other parts of the world such as Europe and Asia.
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To date, there are no therapeutic solutions for patients with severe gastrointestinal infections. Since the oral route is compromised, the available treatments, which are mostly oral treatments, struggle to reach 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 (IV), do not cross the gastrointestinal barrier and therefore do not reach the site of infection.