US Department of Defense to fund Immuron in combatting gastrointestinal infections

Microbiome company Immuron (ASX: IMC), a firm that specialises in developing oral immunotherapeutic treatments for gut mediated diseases, has struck a $5.5 million deal with the US Department of Defense to engineer an effective therapeutic for traveller’s diarrhoea.

More specifically, the US-based Naval Medical Research Center (NMRC) will fund the newly created research agreement with Immuron that will commence immediately. The focus of the research will be to develop a combined ‘campylobacter’ and ‘enterotoxigenic E.coli’ anti-microbial product for clinical evaluation.

Under the terms of the agreement, Immuron and NMRC will collaborate on the manufacture and evaluation of a new product designed to combat gastrointestinal ailments with the ultimate goal of commercialising the product and making it available to US troops.

The root cause of travellers’ diarrhoea is known to be caused by campylobacter and ETEC pathogens, with both expected to form the focus of the collaborative research agreement.

Immuron has confirmed that the protective efficacy of the finished product will be tested utilising two controlled human infection-model clinical trials – one trial focusing on the ability of the product to shield against campylobacteriosis, and the second trial focusing on ETEC infections.

Global disease burden

Campylobacter is a leading cause of gastroenteritis globally caused by the ingestion of contaminated food, water, or contact with animals carrying campylobacter bacteria.

Meanwhile, infectious diarrhoea is the most common illness reported by travellers visiting developing countries and among US troops deployed overseas.

The ailment decreases daily performance, affects judgment, decreases morale and declines operational readiness with very few effective treatments currently available aside from antibiotics – a treatment that is gradually waning due to greater bacterial resistance.

According to researchers, the global burden of diarrheal diseases outweighs any of the more complex diseases seen in gastroenterology clinics. Every year, there are an estimated 1.5 billion episodes of diarrhoea worldwide that result in the deaths of approximately 2.2 million people.

Over the past decade, several enteric pathogens have exhibited an increased resistance to commonly prescribed antibiotics with travellers’ diarrhoea now recognised by the medical community to result in “post-infectious sequelae”, such as gastrointestinal, neurological and joint disorders including irritable bowel syndrome, Crohn’s disease and other autoimmune diseases.

“Despite robust research efforts to develop vaccines against major enteric pathogens, there are currently no licensed vaccines available. To address this unmet need, we will be utilising our own vaccine expertise along with Immuron’s proprietary technology platform to develop an oral preventative product which directly targets pathogenic bacteria at the site of infection within the gastrointestinal tract,” said Dr Frédéric Poly, Head of the Campylobacter research division, Enteric Diseases Department at NMRC.

Dr Poly explained that the NMRC has previously shown that the ETEC vaccine is immunogenic in small animal models and demonstrated that campylobacter jejuni vaccines were 100% protective against campylobacteriosis in the non-human primate model.

“The ultimate goal of this research effort is to lay the scientific foundation for the development of a multi-pathogen product that confers protection against both C. jejuni and ETEC, the predominant causes of infectious diarrhoea in deployed warfighters,” said Dr Poly.

Expansion potential

The data generated from Immuron’s development is expected to provide military policymakers with information needed to make decisions on product acquisition and, if successful, Immuron could be tasked with manufacturing its newly-developed product “at scale” to meet the needs of military personnel on an ongoing basis.

Immuron has also confirmed that it is making regulatory progress with “FDA planning underway” which (if approved) would create a pathway to the US market, the largest healthcare market in the world.

“Along with our current program with the Walter Reed Army Institute of Research which is focused on Shigella, this project highlights the continued commitment Immuron is making to use our hyperimmune bovine polyclonal colostrum technology to benefit the US military as well as the civilian population,” said Dr Gary Jacob, chief executive officer of Immuron.

“This program also further enhances our efforts to raise the profile of our flagship product Travelan and our in-house clinical program to develop IMM-124E as an FDA-approved drug to prevent travellers’ diarrhoea,” he added.

Existing US sales

In addition to its combination of research projects with the NMRC and the Walter Reed Army Institute, Immuron is already marketing its Travelan product across the US.

Earlier this year, the company revealed that its full-year 2019 revenues in North America had grown by more than 50% to reach $1.16 million, driven by its Travelan gastrointestinal and digestive prophylactic health supplement.

This revenue sales figure exceeded $1 million for the first time, with product sales increasing more than 32% year-on-year to reach $1.02 million in FY2019.

Immuron’s shares added over 33% to trade at $0.14 per share by mid-morning.