Immuron Ltd. (NASDAQ: IMRN), an Australian microbiome biopharmaceutical company focused on developing and commercializing oral immunotherapeutics for the prevention and treatment of many gut mediated pathogens, on Wednesday provided shareholders with an update on the company’s cooperative research and development agreements with the U.S. Department of Defense.
Here are the highlights:
- Travelan® pre-clinical shigellosis challenge studies in non-human primates (NHP) successfully completed
- Travelan® prevented clinical shigellosis (bacillary dysentery) in 75% of Travelan® treated NHPs compared to placebo.
- A preventative treatment that protects against enteric diseases, specifically Shigella, is a high priority objective for the U.S. Army
The Backstory: The Department of Defense commissioned several studies to characterize the antibodies within Travelan®, the company’s commercially available flagship over-the-counter gastrointestinal and digestive health supplement. The aim was to conduct trials to determine the product’s effectiveness in neutralizing pathogenic gastrointestinal bacterial infections as a preventative treatment for U.S. military personnel and civilians stationed or traveling in locations where such infections may be debilitating.
The U.S. Armed Forces Research Institute of Medical Sciences (AFRIMS), an overseas laboratory of the Walter Reed Army Institute of Research (WRAIR), located in Bangkok, Thailand, conducted the study that evaluated the therapeutic potential of Travelan® in a non-human primate (NHP) preclinical challenge model that closely mimics the disease seen in humans. The study was performed in collaboration with the Department of Enteric Diseases and the Department of Veterinary Medicine, AFRIMS, and the Department of Enteric Infections, Bacterial Diseases Branch, WRAIR.
The placebo-controlled study was carried out in 12 NHPs segregated into 2 groups: a Travelan® treatment cohort of 8 and a placebo cohort of 4, which were treated with either Travelan® or placebo respectively twice daily for a total of 12 doses over a 6-day period. The animals received treatment for 3-days prior to oral challenge with ~3 x 109 viable Shigella flexneri strain 2a organisms. All (4 of 4 - 100%) placebo-treated animals displayed acute dysentery symptoms within 24 – 36 hours of Shigella flexneri 2a challenge. A single (1 of 8 – 12.5%) of the Travelan®-treated cohort displayed dysentery symptoms at this time point. The remaining individuals (7 of 8 – 87.5%) in the Travelan® treatment cohort remained symptom-free to 4-days post Shigella flexneri 2a challenge. Once the treatment period was concluded a second individual in the Travelan® treatment group developed symptoms (2 of 8 - 25%).
Key Quote: “Travelan® was designed to target selected surface antigens from the most common strains of Enterotoxigenic E. coli (ETEC), bacteria which play a dominant and causative role in traveler’s diarrhea. Previous studies found several of these antigens are shared with bacillary dysentery-causing organisms such as Shigella species. The work completed at AFRIMS highlighted for the first time that in a preclinical NHP challenge model of shigellosis (also known as bacillary dysentery), Travelan® protected 75% of the animals from clinical bacillary dysentery. All the placebo-treated animals displayed classic dysentery symptoms after challenge with a virulent strain of Shigella sp. It is also very interesting to note the second case of dysentery in the Travelan® cohort developed once the treatment terminated.” Dr. Jerry Kanellos, CEO of Immuron
Disclosure
Immuron Ltd. (IMRN) is a client of RedChip Companies, Inc. IMRN agreed to pay RedChip Companies, Inc. a monthly cash fee for 12 months of investor awareness services.