According to a press release written by French biotech company Deinove and published by PM360, the pharmaceutical manufacturer stands ready to begin phase 2 testing into their experimental Clostridium difficile infection (CDI) drug DNV3837.
About Clostridium Difficile
Clostridium difficile is a common bacteria, and it’s one of the leading causes of healthcare associated infections. It typically affects older adults who have spent long amounts of time in the hospital or an elderly home. Individuals who get sick from C. difficile often do so after previously receiving antibiotic medication.
Mild cases typically just result in some gastrointestinal distress (watery bowel movements and mild stomach cramping). More severe cases might involve severe adverse effects like weight loss, nausea, heart palpitation, or even kidney failure. An estimated 40% of CDI cases are severe, and as many of half of these cases will result in deaths. The need for a new treatment is obvious and pressing.
Though the elderly are the most vulnerable to infections stemming from C. difficile, scientists have observed a recent uptick in rates of CDI infection among classically low-risk individuals. These low-risk persons include even young, healthy adults who have forgone prior antibiotic use.
About the DNV3837 Trial
DNV3837 is an antibiotic. Despite the issues commonly associated with prior antibiotic use in C. difficile infections, DNV3837 displayed a promising tolerability and safety profile in earlier phase 1 clinical testing. The FDA subsequently approved the drug’s advancement into phase 2 testing. The news is exciting given that C. difficile will infect about a half million people this year in the United States alone.
The drug is administered as an intravenous injection, and unlike other drugs can pass through the selective G.I. (Gastrointestinal) barrier. The ability to penetrate some of the body’s most advanced defenses lets the drug more accurately target suspected sites of infection. Certain studies have shown that DNV3837 can effectively eliminate C. difficile bacteria from the intestine without seriously risking the important, naturally-occurring gut bacteria as collateral damage.
Though the news is exciting, it’s important to note that the drug has successfully completed only the phase 1 portion of clinical study. Phase 1 studies are mostly concerned with whether or not the drug candidate itself presents harm to the patient, and have little to do with evaluating the drugs’ effectiveness in treating disease. Efficacy tests are usually conducted in phase 2 and 3 trials, meaning we’ll soon get some idea as to whether or not DNV3837 actually works in preventing C. difficile infection.
If Deinove can successfully produce quality data in their phase 2 study (ideally replicating positive results observed in the phase 1 study), they will likely start preparing DNV3837 for marketing. That involves a lot of prep work, including picking a more appealing product name than DNV3837. If the phase 2 trial shows that the drug is not up to snuff, however, it’s back to the drawing board for both the French pharmaceutical company and the many hundreds of thousands of Americans infected with C. difficile.
Healthcare-associated infection is a significant vector for illness in the United States. Do you think more research should be conducted into preventing serious infections that originate in what are meant to be our medical strongboxes? Share your thoughts with Patient Worthy!
