On December 22, 2015, We announced our results for the completion of our pre-clinical proof-of-concept (POC) program in Clostridium Difficile (C.Difficile). The results are highly promising, showing an 80% efficacy in both treatment and prevention of C. Difficile infections without the use of antibiotics.
The study - completed by Immuron Ltd in collaboration with Professor Lyras and her team at Monash University - looked at IMM-529 C.Difficile vaccines for characterization and pre-clinical POC studies for animal efficacy trials. Additional announcements about the study will be forthcoming as we, and Monash University continue to analyse these results. We aim for the results to be published as soon as possible and hope to present the findings at a conference in 2016.
C.Difficile infections are proving to be a major medical problem, with an estimated 28,000 deaths annually attributed to the disease. An approximate ~100000 individuals are affected by recurrent C.Difficile in the U.S annually and it is estimated that the economic burden caused by the disease is upwards of USD $10 billion each year, globally.
Current therapies are based on antibiotics with limited efficacy, causing the disease to commonly recur. Immuron’s program is unique in that it targets both toxin B (a cytotoxin produced by C.diff) and the vegetative cells which are thought to be the primary cause of c.dif recurrences. It is also a natural product, making it preferable to antibiotic treatments that can harmfully affect the microbiome.
Results for immuron’s animal recurrence studies will be available this January. Positive results in the study would conclude that IMM-529 would be beneficial in treatments for all three phases of the disease, prevention, initial treatment, and recurrence, with recurrence being the largest unmet need in the fight against c.diff.
Professor lyras is a world leading expert in this disease having published some of her work in Nature.