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 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).
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 II clinical Trial for Travellers’ Diarrhoea USA
The double-blind randomized placebo controlled phase 2 clinical study will evaluate the safety and protective efficacy of Travelan® in a controlled human infection model involving challenge with Enterotoxigenic E.coli (ETEC). The primary efficacy outcome is prevention and/or reduction of moderate to severe diarrhea. 60 volunteers were 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 commenced in July 2023 ClinicalTrials.gov Identifier: NCT05933525.
The inpatient challenge phase of the Travelan clinical study led by Principal Investigator Dr Mohamed Al-Ibrahim at the Pharmaron CPC FDA inspected Clinical Research Facility Inpatient Unit located in Baltimore, Maryland US, has been completed. The double-blind study was separated into two cohorts of approx. 30 subjects (60 in total) dosed with Travelan or placebo for two days prior to challenge continuing for a total of 7 days. All study participants were challenged with Escherichia coli, monitored for symptoms and treated with antibiotics. Safety data at two weeks and 4 weeks post challenge has been collected and the final 6 month follow up interviews will be initiated in January 2024 and are expected to be completed in April 2024. Headline results from the clinical trial are anticipated to be reported in June 2024.
Infectious diarrhoea is the most common illness reported by travellers’ visiting developing countries and the leading cause of Travellers’ Diarrhoea (TD) is enterotoxigenic Escherichia coli (ETEC). Travelan contains ETEC-specific antibodies that can protect against the clinical symptoms of TD. Immuron is pursuing an FDA clinical pathway with Travelan 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). In December 2023 approx. 50% recruitment for this study was completed.
3. IMM-529 – Clostridioides Difficile Infection(CDI)
Immuron is embarking on a new clinical development program that will focus on treating patients who suffer from Clostridioides Difficile infection. C. difficile is a gram-positive, toxin-producing, spore-forming bacterium that generally causes severe and persistent diarrhoea 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.
Immuron ‘s manufacturing campaign for a new therapeutic product which targets the Clostridioides Difficile (C. Diff) bacteria, IMM-529 drug substance was completed in December 2023 by CSIRO Agriculture and Food. IMM-529 is the second therapeutic drug candidate the company is planning to take into the clinic and has been specifically developed to target (i) toxin B, (ii) spores and (iii) vegetative cells of Clostridioides Difficile (C. Diff) which are thought to be the primary cause of C. Diff disease recurrences. A research services agreement has recently been executed with Monash University to assist with vaccine manufacture and stability testing of the Investigational Medical Product to support the pre-IND information package. A research services agreement has also been executed with VivoPharm Global Preclinical Services to conduct a GLP compliant toxicity study in rodents. The study protocol has been submitted and approved by the Animal Ethics Committee and the study is planned to commence in Q1 2024. The company is working towards submitting a Pre-IND information package to the U.S. Food and Drug Administration (FDA) in H1 2024.
4. NMRC research collaboration: new therapeutic targeting Campylobacter and ETEC infections
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.
The NMRC has recently completed the in-patient stage of the campylobacter challenge clinical study. The clinical study is being led by Principal Investigator Dr Kawsar Talaat, MD at the Johns Hopkins University (JHU) Center for Immunization Research (CIR) Inpatient Unit, located at the JHU Bayview Medical Campus, Baltimore, Maryland. U.S. A total of 30 participants were enrolled in the study, of which 27 participants were dosed with either the Investigational Medical Product or placebo and all subjects were challenged with Campylobacter. All study volunteers have now been treated with antibiotics and discharged from the clinic. The study participants will return as outpatients for several follow-up visits, with the last patient last visit scheduled to be completed in June 2024. Headline results from the clinical trial are anticipated to be reported in H2 2024. The Phase 2 clinical trial is designed to evaluate the safety and protective efficacy of the new product manufactured by Immuron compared to a placebo in a controlled human infection model (CHIM). The primary efficacy outcome is prevention and/or reduction of moderate to severe diarrhea. ClinicalTrials.gov Identifier: NCT06122870.
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.
