Product Pipeline

Immuron is pursuing multiple research and development pathways to realise the potential of its proprietary technology platform. The company presently has three drug candidates in clinical development and several in early stage preclinical development. Immuron believes its therapeutic drug candidates have the potential to transform the existing treatment paradigms for moderate to severe Campylobacteriosis, recurrent Clostridiodes difficile (C.difficle) infections, Enterotoxigenic Escherichia coli (ETEC) infections, Shigellosis (Bacillary dysentery) and travelers’ diarrhea (a digestive tract disorder that is commonly caused by pathogenic bacteria and the toxins they produce).

 

1. Commercial Products

Immuron’s flagship product Travelan® is commercially available in 3 global markets. In Australia Travelan is sold as an over-the-counter medicine to reduce the risk of Travellers’ Diarrhoea and reduce the symptoms of minor gastro-intestinal disorders. It is listed on the Australian Register of Therapeutic Goods (AUST L 106709). In Canada Travelan® is a licensed natural health product (NPN 80046016)) that is indicated to reduce the risk of Travellers’ Diarrhoea. In the USA, Travelan® is sold as a dietary supplement to support digestive health.

Protectyn® (AUST L 231001) is marketed as an immune supplement to help maintain a healthy digestive function and liver. It is currently sold in practitioners’ offices in Australia can also be purchased online via the Immuron website.

2. Travelan (IMM-124E)

i. FDA Phase III registration Trial for Travellers’ Diarrhoea USA

The company recently completed a pre-IND meeting with the U.S. Food and Drug administration (FDA) and has commenced work on an investigational new drug (IND) application for IMM-124E which the company is developing to reduce the risk of contracting travelers’ diarrhea (TD) in individuals traveling to areas where TD is endemic. FDA approval for Travelan® (IMM-124E), will allow the product to be marketed in the USA as a drug to reduce the risk of contracting Travellers’ Diarrhoea.

ii. Phase II Field Trial for Travellers’ Diarrhoea

The US Navy Medical Research Centre and the Uniformed Services University (USU) Infectious Disease Clinical Research Program (IDCRP) in collaboration with the UK Ministry of Defense and the New York City Travel Clinic are jointly conducting a randomized clinical trial to evaluate the efficacy of non-antibiotic OTC products in Travelers’ Diarrhea and inform strategies for Force Health Protection.

The P4TD study is a randomized, double-blind, placebo controlled multicenter clinical trial designed to evaluate the effectiveness of 3 commercially available nutraceuticals: A prebiotic (Bimuno®), a probiotic (Florastor®) and IMM-124E (Travelan®) passive immunoprophylaxis versus a placebo, for prophylaxis during deployment or travel to a high-TD risk region. All study participants (1336 in total) will be randomized to one of the three active products or placebo (334 per arm).

iii. COVID-19 Research

Laboratory testing of IMM-124E demonstrated anti-viral activity against SARS-CoV-2, the virus that causes COVID-19. The preliminary research data generated, demonstrated the potential for a new therapeutic approach to target SARS-CoV-2 in the gastrointestinal tract where COVID-19 causes inflammation. Immuron has filed a provisional patent application to extend its intellectual property over the findings and is engaging with potential international research collaborators to advance this work.

3. IMM-529 – Recurrent Clostridiodes Difficile Infection(CDI)

Immuron is embarking on a new clinical development program that will focus on treating patients who suffer from recurring Clostridium Difficile infection. C.difficile is a gram-positive, toxin-producing, spore-forming bacterium that generally causes severe and persistent diarrhea in infected individuals, but can also lead to more severe outcomes, including in the most serious cases, death. CDI is most often associated with the prior use of antibiotics. The U.S. Centers for Disease Control has identified CDI as one of the top three most urgent antibiotic-resistant bacterial threats in the U.S. and is now the most common cause of hospital acquired infection in the U.S. CDI is a challenging disease, with a recurrence rate of 15%–20% and a mortality rate of 5% and represents an unmet medical need.

IMM-529, targets the C. difficile bacterium and contains polyclonal antibodies cross-reactive to Toxin B, spores and vegetative cells of the bacterium. IMM-529 is an oral biologic which does not destroy the microbiome like antibiotic treatments, allowing the microbiome to return to a healthy state, while treating the virulent CDI. The antibodies in IMM-529 have been demonstrated to be cross-reactive with a variety of human and animal C.difficile isolates and to their associated Toxin B, vegetative cells and spore components.

4. NMRC research collaboration: new therapeutic targeting Campylobacter and ETEC infections

The Naval Medical Research Center (NMRC) has executed a research agreement with Immuron to develop and clinically evaluate a new therapeutic targeting Campylobacter and ETEC infections.The NMRC received written guidance from the U.S. Food and Drug administration (FDA) in relation to the clinical development pathway of the new drug which the company is developing to treat moderate to severe campylobacteriosis and Enterotoxigenic Escherichia coli (ETEC) infections. The Type B meeting with the FDA discussed the Chemistry, Manufacturing and Controls including the proposed release testing specifications of the product as well as the planned clinical studies evaluating the safety and efficacy of the product. Work on the Investigational New Drug application has been initiated. The protective efficacy of the product will be evaluated in two controlled human infection model clinical trials scheduled to commence in 2021.

5. Development of Shigella specific therapeutic

This collaboration with the Walter Reed Army Institute of Research (WRAIR) aims to develop an oral therapeutic for shigellosis, a severe form of dysentery that affects about 165 million people a year, mostly children, and causes up to a million deaths. Symptoms of shigellosis, also known as bacillary dysentery, include severe and bloody diarrhea, fever, and stomach cramps.We have completed of the manufacture of three new Shigella-specific therapeutic products using proprietary vaccines developed by WRAIR. The immune reactivity of the three hyper-immune Shigella specific products were evaluated by the WRAIR using Enzyme Linked ImmunoSorbent Assay and Western Blot analysis. The antibodies in the products were shown to react with the specific antigens present in the vaccines. The antibodies within the three products were also reactive to 4 different clinical isolates of Shigella (S.flexneri 2a, S.flexneri 3a, S.flexneri 6, and S.sonnei). The therapeutic efficacy of the three Immuron Shigella-specific therapeutic products are currently being evaluated by the WRAIR using preclinical animal models of shigellosis.