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 Clostridioides 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).
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.
i. FDA Phase II clinical Trial for Travellers’ Diarrhoea
The double-blind randomized placebo controlled phase II clinical study will evaluate the safety and protective efficacy of a single daily dose of Travelan® in a controlled human infection model involving challenge with Enterotoxigenic E.coli (ETEC). Up to 60 volunteers will be recruited for the study who will be randomized to receive either 1200mg of Travelan or placebo daily. Immuron was awarded an IND from the U.S. Food and Drug administration (FDA) in December 2022, for the study which is due to commence in 2023.
Infectious diarrhoea is the most common reported illnesses by travellers visiting developing countries and the leading cause of traveller’s diarrhoea (TD) is enterotoxigenic Escherichia coli (ETEC). Travelan contains ETEC-specific antibodies that can protect against the clinical symptoms of TD. The once daily dosing of Travelan will contribute to the FDA approval process to allow the product to marketed in the USA as a drug to reduce the risk of contracting TD.
ii. Field Trial for Travellers’ Diarrhoea
The U.S Naval Medical Research Center (NMRC) 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 Travellers’ Diarrhoea (TD) and inform strategies for Force Health Protection.
The clinical study is a randomized, double-blind, placebo controlled multicenter clinical trial designed to evaluate the effectiveness of IMM-124E (Travelan®) passive immunoprophylaxis versus a placebo, for prophylaxis during deployment or travel to a high-TD risk region. The study is currently recruiting ClinicalTrials.gov Identifier: NCT04605783. All study participants (868 in total) will be randomized to Travelan® or placebo (434 per arm).
Immuron is embarking on a new clinical development program that will focus on treating patients who suffer from recurring Clostridioides 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.
The U.S Naval Medical Research Center (NMRC) has executed a research agreement with Immuron to develop and clinically evaluate a new therapeutic targeting Campylobacter and Enterotoxigenic Escherichia coli (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 ETEC infections. In May 2023, the FDA approved the IND application to test the safety and protective efficacy in a first-in man study. Two human infection model clinical studies involving challenge with ETEC and Campylobacter are planned, the first study is due to commence in 2023.
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.