Immuron (ASX:IMC) files FDA application for deadly C. diff infection fight

Immuron has filed a pre-investigational new drug application with the United States Food and Drug Administration for IMM-529, designed as a new therapeutic to prevent and treat recurrent Clostridioides difficile infection

The colon-inflaming condition caused by the bacteria C. diff afflicts over 400,000 people in the US every year, contributing to over 30,000 deaths annually.

The condition results from disruption of normal, healthy bacteria, and is often the result of antibiotics treatments as increased resistance continues to amplify their worldwide use.

While treating the infection also often involves using antibiotics, faecal implants or a combination of the two, heavy reliance on antibiotics alone does not always allow for gut flora to regenerate, resulting in a likely relapse.

C. diff is currently the most common pathogen in healthcare-associated infections and was qualified as an urgent threat in the Center for Disease Control and Prevention’s report on antibiotic resistance threats in the US.

Immuron is developing IMM-529 as an adjunctive oral preventative to work alongside antibiotics, believing its antibodies’ targeting of the bacteria may help to clear infection and be faster at promoting a healthy gut.

The Melbourne-based pharmaceutical company will work alongside Dr Dena Lyras and her team at the city’s Monash University to develop vaccines to produce antibodies derived from cows.

The dairy animals were immunised to generate a hyperimmune bovine colostrum which contains antibodies targeting three essential bacterial virulence components in a unique three-prong approach showing promise in pre-clinical infection and relapse models.

To Immuron’s knowledge it is the only investigational drug to date that has shown therapeutic potential across all three phases of the disease.

If efficacy is proven, an opportunity assessment has shown the result would position the drug to be uesd as early in the treatment algorithm as payers will allow.

Immuron believes its use on a second recurrence would be the most likely, but some doctors looking to treat the infection aggressively may turn to an earlier use.

A conservative second-recurrence use case has been used to estimate eligibility for about 31,000 patients and a base-case yearly revenue projected upwards to US$93 million.

Immuron’s technology base is centred around generating a hyper-immune bovine colostrum rich in antibodies, with the company believing it holds a major advantage in its capability to produce highly specific and orally active products.

The value of products using similar technology derived from human plasma currently exceeds $16 billion dollars in annual revenue across the US.

“We are excited for our third therapeutic to be heading towards phase 2 clinical studies, demonstrating the utility of our technology platform,” Immuron Chief Executive Steven Lydeamore said.

Immuron is also looking towards pivotal phase 3 clinical trials for its over-the-counter immune supplement Travelan after more positive results.

The company also has phase 2 trials underway in a partnership with the US’ Naval Medical Research Command to investigate the capacity of its CampETEC product to treat infectious diarrohea caused by the Campylobacter bacteria.

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