The independent monitoring and follow-up committee in charge of the phase II study developed by Deinove in the context of the fight against Clostridioides difficile infections, caused by an intestinal bacterium, has issued a favorable opinion in terms of benefit/risk .
Deinove receives a favorable opinion for a phase II study | Photo credits: Deinove
Good news for Deinove, whose phase II study of its drug candidate DNV3837 in Clostridioides difficile infections (CDI) has just received a favorable opinion from the independent monitoring and monitoring committee (Data Safety Monitoring Board or DSMB) in charge of this study. The DSMB, which can, by virtue of its powers, make recommendations concerning the continuation, modification or termination of the trial, thus judged that the benefit/risk balance of antibiotic therapy with DNV3837 was in favor of the continuation of the test.
Clostridium difficile is a bacterium naturally present in the intestines of 3% of adults and 66% of children. It does not pose a problem for healthy individuals. But the antibiotics used to treat certain illnesses can alter the balance in the gut and cause disruption. The infection manifests itself physically in mild to severe diarrhea, blood in the stool, fever and stomach cramps. It is highly contagious and sometimes fatal.
No effective antibiotics
In the United States, CDIs are the most common nosocomial infections, with around 223,900 cases among hospitalized patients and 12,800 deaths in 2017, according to data presented on the Deinove website. In Europe, nosocomial infections are estimated at 152,905 cases and 8,382 deaths each year.
” To date, no antibiotic can effectively treat severe Clostridioides difficile gastrointestinal infections due to the nature of the disease.explains the company again. Oral treatments have difficulty reaching the intestine due to frequent bowel movements, colitis, or intestinal paralysis, and intravenous antibiotics fail to effectively penetrate the gastrointestinal barrier to reach the site of infection. »
” This positive opinion from the DSMB is an important step for the development of the DNV3837indicates the CEO of Deinove, Alexis Rideau (…) We fell behind during the first part of the trial due to the Covid-19 pandemic. The forthcoming opening of new centers and a simpler protocol for investigators should facilitate recruitment. »
The announcement is greeted on the stock market by a gain of 18% of the action, but at a low level of 51 cents. The action always loses half of its value over a year.
