Immuron requests pre-IND meeting for IMM-529 with FDA filing

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Immuron (ASX: IMC; NASDAQ: IMRN) has filed a pre-IND application with the FDA for IMM-529, aimed at treating recurrent Clostridioides difficile infections (CDI). CDI affects over 400,000 people annually in the U.S., causing over 30,000 deaths. IMM-529 is being developed as an adjunct therapy to standard antibiotics, targeting Toxin B, spores, and vegetative cells of C. diff. Pre-clinical studies have shown promising results, including 80% prevention of primary disease and 67% protection against recurrence. The projected base case yearly revenue for IMM-529 is US$93 million, with potential expansion to US$141 million if used for first recurrence patients. The drug's oral dosing is considered advantageous over current complex treatments. Immuron is working with Monash University to produce antibodies from bovine colostrum. The PR highlights the urgent need for new CDI treatments due to rising antibiotic resistance.

  • Pre-IND application for IMM-529 filed with the FDA.
  • IMM-529 targets Toxin B, spores, and vegetative cells of C. diff.
  • Promising pre-clinical results: 80% prevention of primary disease and 67% protection against recurrence.
  • Projected base case yearly revenue for IMM-529 is US$93 million.
  • Potential revenue expansion to US$141 million if used for first recurrence patients.
  • Oral dosing of IMM-529 is viewed positively by experts.
  • IMM-529 may address the urgent need for new CDI treatments due to rising antibiotic resistance.
  • The drug's market success depends on payer restrictions and competition.
  • The projected revenue assumes aggressive use within the target patient population, which may not be guaranteed.

The development of IMM-529 as an adjunctive therapy for recurrent Clostridioides difficile infection (CDI) presents an intriguing advancement in the fight against antibiotic-resistant bacteria. CDI's prevalence and its associated morbidity and mortality rates underscore the importance of novel therapeutic approaches.

IMM-529's mechanism of action—targeting Toxin B, spores and surface layer proteins—leverages a multi-faceted approach which is promising considering the high recurrence rates of CDI following conventional antibiotic treatment. The pre-clinical results showing significant prevention, protection against disease recurrence and treatment efficacy are indeed noteworthy. This implies potential for IMM-529 to not only treat but also prevent recurrent infections, thereby addressing a critical unmet need in CDI management.

Moreover, the oral dosing form of IMM-529 is particularly advantageous for patient compliance compared to more complex current treatments like fecal microbiota transplantation (FMT) or intravenous bezlotoxumab.

The potential market for IMM-529 is significant. If IMM-529 is positioned for use at the second recurrence of CDI, it could potentially reach up to 31,000 patients, expanding to 95,000 if used at the first recurrence. This implies a substantial revenue opportunity, with a base case yearly revenue of US$93M, which could increase by an additional US$48M if it captures even a small percentage of first recurrence patients.

The cost and complexity of current advanced CDI treatments make IMM-529's oral administration an attractive alternative, likely driving adoption among healthcare providers and patients. However, payer restrictions and competition in the market must be closely monitored as they could impact the drug's market penetration.

MELBOURNE, Australia, July 02, 2024 (GLOBE NEWSWIRE) -- Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and globally integrated biopharmaceutical company, is pleased to announce that it has filed a pre-IND (investigational new drug) application with the United States Food and Drug Administration (FDA) for IMM-529.

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

The increased incidence of antibiotic resistant ‘superbugs’ has amplified the use of broad-spectrum antibiotics worldwide. An unintended consequence of antimicrobial treatment is disruption of the gastrointestinal microbiota, resulting in susceptibility to opportunistic pathogens, such as Clostridioides difficile (C. diff). Paradoxically, treatment of Clostridioides difficile infection (CDI) also involves antibiotic use, and the heavy reliance on antibiotics to control C. diff does not allow for the gut flora to regenerate and predisposes the patient to relapsing CDI. C. diff is currently the most common pathogen in healthcare-associated infections and was deemed an urgent threat in the Center for Disease Control and Prevention’s report on antibiotic resistance threats in the United States (CDC, 2019). CDI affects over 400,000 people in the US on a yearly basis, contributing to over 30,000 deaths in the US alone annually. This serious health threat has led to an urgent call for the development of new therapeutics to reduce or replace the use of antibiotics to treat bacterial infections.

To address this need, Immuron is developing IMM-529 as an adjunctive therapy in combination with standard of care antibiotics for the prevention and/or treatment of recurrent CDI. IMM-529 antibodies targeting C. diff may help to clear CDI infection and promote a quicker re-establishment of normal gut flora, providing an attractive oral preventative for recurrent CDI.

Immuron is collaborating with Dr. Dena Lyras and her team at Monash University, Australia to develop vaccines to produce bovine colostrum-derived antibodies. Dairy cows were immunised to generate hyperimmune bovine colostrum (HBC) that contains antibodies targeting three essential C. diff virulence components. IMM-529 targets Toxin B (TcB), the spores and the surface layer proteins of the vegetative cells (refer to MOA schematic - below).

This unique 3-target approach has yielded promising results in pre-clinical infection and relapse models, including (1) Prevention of primary disease (80% P =0.0052); (2) Protection of disease recurrence (67%, P <0.01) and (3) Treatment of primary disease (78.6%, P<0.0001; TcB HBC). Importantly IMM-529 antibodies cross-react with whole cell lysates of many different human strains of C. diff including hypervirulent strains.

To our knowledge, IMM-529 is, to date, the only investigational drug that has shown therapeutic potential in all three phases of the disease.

IMM-529 MOA in CDI - Targets Spores, Vegetative Cells, and Toxin B

Opportunity assessment by Lumanity indicates that if efficacious, IMM-529 will be positioned as early in treatment algorithm as payers will allow. Second recurrence appears to be most likely (after one course each of fidaxomicin and vancomycin) but some doctors who treat aggressively or see a patient as being especially high-risk may be willing to turn to IMM-529 even earlier. Up to ~31k patients would be eligible if IMM-529 is positioned at the second recurrence, and up to ~95k patients would be eligible if positioned at the first recurrence. Based on the estimated market size, anticipated payer restrictions, pricing, and competition, base case yearly revenue for IMM-529 is projected at US$93M. The estimate of $93M represents a conservative view of the target patient population (limited to 2nd recurrence and later by trial design and payer coverage) but likely aggressive use (75%) within that target patient population. Greater efficacy may lead to greater use in patients after their first recurrence, increasing the size of the patient population. Even capturing as few as 10% of first recurrence patients adds up to 9,500 patients to the treated pool (potential for some double counting), which could add up to US$48M in yearly revenue. Oral dosing of IMM-529 was viewed as a positive by infectious disease experts, particularly since current advanced CDI treatment approaches (e.g., bezlotoxumab, fecal microbiota transplantation) are expensive and complex in their administration.

This release has been authorised by the directors of Immuron Limited.

Steven Lydeamore
Chief Executive Officer

About Immuron
Immuron Limited (ASX: IMC, NASDAQ: IMRN), is an Australian biopharmaceutical company focused on developing and commercializing orally delivered targeted polyclonal antibodies for the treatment of infectious diseases.

Immuron Platform Technology
Immuron’s proprietary technology is based on polyclonal immunoglobulins (IgG) derived from engineered hyper-immune bovine colostrum. Immuron has the capability of producing highly specific immunoglobulins to any enteric pathogen and our products are orally active. Bovine IgG can withstand the acidic environment of the stomach and is resistant to proteolysis by the digestive enzymes found in the Gastrointestinal (GI) tract. Bovine IgG also possesses this unique ability to remain active in the human GI tract delivering its full benefits directly to the bacteria found there. The underlying nature of Immuron’s platform technology enables the development of medicines across a large range of infectious diseases. The platform can be used to block viruses or bacteria at mucosal surfaces such as the Gastrointestinal tract and neutralize the toxins they produce.

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This press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition, and stock value. Factors that could cause actual results to differ materially from those currently anticipated include: risks relating to our growth strategy; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; risks relating to the results of research and development activities; risks relating to the timing of starting and completing clinical trials; uncertainties relating to preclinical and clinical testing; our dependence on third-party suppliers; our ability to attract, integrate and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions, or circumstances on which any such statement is based, except as required by law.

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What is Immuron's new FDA filing related to?

Immuron has filed a pre-IND application with the FDA for IMM-529, aimed at treating recurrent Clostridioides difficile infections (CDI).

What is IMM-529 designed to treat?

IMM-529 is designed to treat recurrent Clostridioides difficile infections (CDI) as an adjunct therapy to standard antibiotics.

What are the projected revenues for IMM-529?

The base case yearly revenue for IMM-529 is projected at US$93 million, potentially expanding to US$141 million if used for first recurrence patients.

What are the pre-clinical results for IMM-529?

Pre-clinical studies show 80% prevention of primary disease and 67% protection against recurrence for IMM-529.

How does IMM-529 work against C. diff?

IMM-529 targets Toxin B, spores, and vegetative cells of C. diff, helping to clear the infection and promote gut flora re-establishment.

Who is Immuron collaborating with to develop IMM-529?

Immuron is collaborating with Dr. Dena Lyras and her team at Monash University to produce antibodies from bovine colostrum for IMM-529.

Why is there an urgent need for new treatments for CDI?

Rising antibiotic resistance and severe health impacts of CDI, affecting over 400,000 people annually in the U.S. and causing over 30,000 deaths, create an urgent need for new treatments.

What are the benefits of IMM-529’s oral dosing?

IMM-529’s oral dosing is advantageous over current CDI treatments, which are often complex and expensive to administer.

Immuron Limited


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