Clostridioides Difficile and VXN-623

Vaxxilon is developing VXN-633, a semi-synthetic vaccine, targeting Clostidioides difficile (C. diff). C. diff. is a leading cause of hospital acquired infections, has high recurrence rates once treated, and is an “Urgent” threat for anti-microbial resistance.

Clostridioides difficile (more commonly known as Clostridium difficile) is a gram-positive, spore-forming, toxin-producing, anaerobic bacterium which is a leading cause of hospital acquired antibiotic-associated diarrhea. It is found widely in the gastrointestinal tract and can cause toxin-mediated C. difficile infections (CDI) that range from mild diarrhea to pseudomembranous colitis and potential death.

C. difficile causes more than 500,000 infections in the United States per year, resulting in an estimated 29,000 deaths. Of these infections, approximately, 1/3 are community acquired in contrast to the common assumption that C. difficile is almost exclusively contracted in hospitals. The number of infections has been increasing dramatically with some estimates as high as 42% per year. Recurrence rates, historically about 25%, have also been increasing. Due to the inherent antibiotic resistance of C. difficile cells and high prevalence of CDI in some hospitals, the Centers for Disease Control and Prevention (CDC) has designated C. difficile as “an urgent threat” for antimicrobial resistance.

C. difficile infection places a significant economic burden on the healthcare system. The acute-care direct costs of CDI in the U.S. were estimated to be $4.8 billion in 2008. Hospital stays during which CDI was a secondary diagnosis were more than twice as long as those with CDI as a principle diagnosis (16.0 vs. 6.9 days) and costs were more than three times higher ($31,500 vs. $10,100).

Currently, antibiotics are the standard treatment for CDI (including vancomycin, metronidazole, or fidaxomicin) but the pathogen is becoming increasingly resistant. CDI recurrence after the initial treatment can be more than 35% in treated patients.

Preventative vaccination could have a substantial impact on infection rates and the associated burden.

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