Immuron Plans Phase 2 Trial for IMM-529 following FDA review

Rhea-AI Summary

Immuron (ASX: IMC; NASDAQ: IMRN) has received positive feedback from the FDA on its pre-IND package for IMM-529, a potential treatment for Clostridioides difficile infection (CDI). The company plans to file an IND application in the first half of 2025, followed by a Phase 2 trial. IMM-529 targets three C. diff virulence components and has shown promising results in pre-clinical models, including prevention of primary disease, protection against recurrence, and treatment of primary disease.

CDI affects over 400,000 people annually in the US, contributing to over 30,000 deaths. Market assessment indicates potential yearly revenue of US$93M for IMM-529 if positioned for second recurrence treatment, with potential for up to US$141M if used after first recurrence. The oral dosing of IMM-529 is viewed favorably by infectious disease experts.

Positive

• FDA provided favorable feedback on IMM-529 pre-IND package
• Plans to file IND application in 1H 2025, followed by Phase 2 trial
• IMM-529 showed promising results in pre-clinical models (80% prevention of primary disease, 67% protection against recurrence, 78.6% treatment of primary disease)
• Potential yearly revenue of US$93M, with possibility of up to US$141M if used after first recurrence
• Oral dosing of IMM-529 viewed positively by infectious disease experts

Negative

• IND application and Phase 2 trial not scheduled until 2025, indicating a long timeline for potential market entry
• Competitive market with existing treatments for CDI
• Revenue projections based on conservative estimates and may not be realized

Insights

Medical Research Analyst

Immuron's progress with IMM-529 for Clostridioides difficile infection (CDI) is promising. The FDA's favorable feedback on the pre-IND package is a significant milestone, paving the way for a planned IND application in 1H 2025. The unique 3-target approach of IMM-529, targeting Toxin B, spores and surface layer proteins, shows potential in addressing the full spectrum of CDI.

Pre-clinical data is encouraging, with 80% prevention of primary disease and 67% protection against recurrence. If these results translate to humans, IMM-529 could be a game-changer in CDI treatment. The oral administration is a notable advantage over current advanced treatments, potentially improving patient compliance and reducing healthcare costs.

However, the path to market is long, with the Phase 2 trial yet to begin. Investors should monitor the IND application process and subsequent clinical trials closely for a better assessment of IMM-529's potential.

Market Research Analyst

The market opportunity for IMM-529 appears substantial. With over 400,000 CDI cases annually in the US and 30,000 deaths, there's a clear unmet need. The projected base case yearly revenue of $93M is conservative but significant for a company of Immuron's size.

The potential to expand into first recurrence patients could boost revenue by an additional $48M yearly. This scalability is attractive, especially if clinical trials demonstrate superior efficacy. The oral dosing form is a competitive advantage, potentially allowing for broader adoption compared to complex, expensive treatments like bezlotoxumab or fecal microbiota transplantation.

However, the market is competitive and success will depend on clinical trial outcomes and pricing strategy. The 2025 IND application timeline suggests a long road to commercialization, requiring patience from investors. Regulatory hurdles and potential shifts in standard of care should be monitored closely.

Key Points

• Immuron completes pre-IND meeting with FDA on the development of IMM-529 as product to specifically prevent or treat Clostridioides difficile infection (CDI)
• Previous clinical trial data on IMM-529 provides support for continued development of IMM-529
• Investigational new drug (IND) application for IMM-529 planned for 1H 2025
  

MELBOURNE, Australia, Sept. 05, 2024 (GLOBE NEWSWIRE) -- Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and globally integrated biopharmaceutical company, is pleased to announce that it has received favourable feedback from the United States Food and Drug Administration (FDA) on the pre-IND (investigational new drug) information package to support the clinical development of IMM-529.

Following the FDA’s guidance and feedback, the Company now plans to file an investigational new drug (IND) application for IMM-529 to prevent or treat Clostridioides difficile infection (CDI) during the first half of 2025, followed by a Phase 2 trial of IMM-529 in individuals with Clostridioides difficile infection.

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. https://doi.org/10.1038/s41598-017-03982-5

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.

COMPANY CONTACT:
Steven Lydeamore
Chief Executive Officer
steve@immuron.com

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.

For more information visit: https://www.immuron.com.au/ and https://www.travelan.com
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FORWARD-LOOKING STATEMENTS:

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.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/0f144d51-c9e9-46ae-93cf-2a7ac93c74d5

FAQ

What is the purpose of Immuron's IMM-529 drug candidate?

IMM-529 is being developed as an adjunctive therapy in combination with standard antibiotics for the prevention and/or treatment of recurrent Clostridioides difficile infection (CDI).

When does Immuron (IMRN) plan to file the IND application for IMM-529?

Immuron plans to file the investigational new drug (IND) application for IMM-529 during the first half of 2025.

What are the key targets of IMM-529 in treating C. difficile infection?

IMM-529 targets three essential C. difficile virulence components: Toxin B (TcB), the spores, and the surface layer proteins of the vegetative cells.

What is the estimated market potential for IMM-529 according to the press release?

The base case yearly revenue for IMM-529 is projected at US$93M, with potential to reach up to US$141M if used after first recurrence of CDI.

What advantages does IMM-529 offer over current CDI treatments?

IMM-529 offers oral dosing, which is viewed favorably by infectious disease experts, especially compared to current advanced CDI treatments that are expensive and complex to administer.