Immuron Submits IMM-529 IND to FDA
Immuron (NASDAQ: IMRN) submitted an IND to the FDA for clinical development of IMM-529 to treat Clostridioides difficile infection (CDI) and prevent recurrent CDI (rCDI). The company plans to initiate a Phase 2 trial in H1 2026 enrolling first-episode and recurrent CDI patients. An independent market analysis estimates an eligible population of ~98,000 patients at first recurrence and a base-case annual revenue potential of ~US$400M pending efficacy. IMM-529 is an oral, three-target polyclonal antibody candidate directed at Toxin B, spores, and surface layer proteins, with preclinical results reporting prevention of primary disease (80% P=0.0052), protection of recurrence (67% P<0.01) and treatment of primary disease (78.6% P<0.0001).
Immuron (NASDAQ: IMRN) ha presentato una IND alla FDA per lo sviluppo clinico di IMM-529 per trattare l'infezione da Clostridioides difficile (CDI) e prevenire la CDI ricorrente (rCDI). L'azienda prevede di avviare una fase 2 nel primo semestre del 2026 arruolando pazienti con CDI nella prima occorrenza e CDI ricorrente. Una analisi di mercato indipendente stima una popolazione eleggibile di circa 98.000 pazienti al primo ricorrenza e un potenziale di ricavo annuo in caso base di circa US$400M in attesa di efficacia. IMM-529 è una candidata anticorpale policlonale orale a tre bersagli diretta contro la Tossina B, le spore e le proteine della superficie, con risultati preclinici che riportano la prevenzione della malattia primaria (80% P=0,0052), la protezione dalla ricorrenza (67% P<0,01) e il trattamento della malattia primaria (78,6% P<0,0001).
Immuron (NASDAQ: IMRN) presentó una IND ante la FDA para el desarrollo clínico de IMM-529 para tratar la infección por Clostridioides difficile (CDI) y prevenir la CDI recurrente (rCDI). La compañía planea iniciar un ensayo de fase 2 en el 1er semestre de 2026 reclutando pacientes con CDI en su primera episodio y CDI recurrente. Un análisis de mercado independiente estima una población elegible de ~98,000 pacientes en la primera recurrencia y un potencial de ingresos anuales en el escenario base de ~US$400M sujeto a eficacia. IMM-529 es un candidato de anticuerpo policlonal oral de tres objetivos dirigido a toxina B, esporas y proteínas de la capa superficial, con resultados preclínicos que reportan prevención de la enfermedad primaria (80% P=0,0052), protección de la recurrencia (67% P<0,01) y tratamiento de la enfermedad primaria (78,6% P<0,0001).
Immuron (NASDAQ: IMRN)는 임상 개발을 위해 FDA에 IND를 제출했습니다 IMM-529는 Clostridioides difficile 감염(CDI)을 치료하고 재발 CDI(rCDI)를 예방하기 위한 것입니다. 회사는 2026년 상반기에 2상 시험을 시작할 계획이며 처음 발병 CDI 환자와 재발 CDI 환자를 모집합니다. 독립적인 시장 분석은 첫 재발 시 약 98,000명의 자격 있는 인구와 기반 시나리오 연간 매출 잠재력을 약 미화 4억 달러로 추정합니다. IMM-529는 경구용으로 세 가지 표적의 다클론 항체 후보이며 독소 B, 포자, 표면층 단백질에 작용하며, 전임상 결과는 일차 질환 예방(80% P=0.0052), 재발 보호(67% P<0.01) 및 일차 질환 치료(78.6% P<0.0001)를 보고했습니다.
Immuron (NASDAQ: IMRN) a soumis une IND à la FDA pour le développement clinique de IMM-529 afin de traiter l’infection à Clostridioides difficile (CDI) et de prévenir la CDI récurrente (rCDI). La société prévoit d’initier un essai de phase 2 au premier semestre 2026 en recrutant des patients atteints de CDI au premier épisode et CDI récurrent. Une analyse de marché indépendante estime une population éligible d’environ 98 000 patients lors de la première récurrence et un potentiel de revenus annuels en scénario de base d’environ US$400M, sous réserve d’efficacité. IMM-529 est une candidat anticorps polyclonal oral à trois cibles dirigé contre la toxine B, les spores et les protéines de la couche superficielle, avec des résultats précliniques rapportant la prévention de la maladie primaire (80% P=0,0052), la protection contre la récurrence (67% P<0,01) et le traitement de la maladie primaire (78,6% P<0,0001).
Immuron (NASDAQ: IMRN) hat eine IND bei der FDA für die klinische Entwicklung von IMM-529 zur Behandlung der Clostridioides difficile-Infektion (CDI) und zur Vorbeugung einer rezidivierenden CDI (rCDI) eingereicht. Das Unternehmen plant, in Phase 2 im ersten Halbjahr 2026 zu starten und sowohl Patienten mit Erstinfektion als auch mit rezidivierender CDI einzuschließen. Eine unabhängige Marktentwicklungsanalyse schätzt eine berechtigte Bevölkerung von ca. 98.000 Patienten bei der ersten Rezidivinfektion und ein Basis-Umsatzpotenzial pro Jahr von ca. US$400 Mio., abhängig von der Wirksamkeit. IMM-529 ist ein oraler, dreifach zielgerichteter polyklonaler Antikörperkandidat, der auf Toxin B, Sporen und Oberflächenproteine abzielt, wobei präklinische Ergebnisse die Verhinderung der Primärkrankheit (80% P=0,0052), den Schutz vor Recidiven (67% P<0,01) und die Behandlung der Primärkrankheit (78,6% P<0,0001) berichten.
Immuron (NASDAQ: IMRN) قدمت IND إلى FDA من أجل التطوير السريري لـ IMM-529 لعلاج عدوى Clostridioides difficile (CDI) ومنع CDI المتكرر (rCDI). تخطط الشركة لبدء اختبار المرحلة 2 في النصف الأول من 2026 يشمل مرضى CDI في أول نوبة ومرضى CDI المتكرر. تحليل سوق مستقل يقدر عدد السكان المؤهلين بنحو ~98,000 مريض في أول تكرر و potential عائد سنوي بنطاق أساسي نحو ~US$400M رهناً بالفعالية. IMM-529 هو مرشح أجسام مضادة بوليكلونال فموي بثلاثة أهداف موجّهة ضد سمّ التوكسين B، والخُسّار، وبروتينات الطبقة السطحية، مع نتائج مخبرية حيوية تُبلغ عن الوقاية من المرض الأول (80% P=0.0052)، حماية من التكرار (67% P<0.01) ومعالجة المرض الأول (78.6% P<0.0001).
Immuron (NASDAQ: IMRN) 已向美国食品与药物管理局提交了 IND，用于临床开发 IMM-529 以治疗艰难梭状芽胞杆菌感染（CDI）并预防复发性 CDI（rCDI）。公司计划在 2026 年上半年 启动一项 2 期试验，招募初次发作和复发 CDI 患者。一项独立市场分析估计首发复发时的符合条件人群约为 98,000 人，基线情景下的年度收入潜力约为 US$400M，前提是有效性。IMM-529 是一种口服、三靶点的多克隆抗体候选药物，靶向 毒素B、孢子和表层蛋白，其药前结果显示可防止原发疾病（80% P=0.0052）、防止复发（67% P<0.01）以及治疗原发疾病（78.6% P<0.0001）。
- IND submission to FDA for IMM-529 targeting CDI
- Phase 2 clinical trial planned to start in H1 2026
- Oral administration favored by infectious disease specialists
- Preclinical efficacy: primary prevention 80% (P=0.0052)
- Preclinical efficacy: recurrence protection 67% (P<0.01)
- Preclinical efficacy: treatment effect 78.6% (P<0.0001)
- Independent market base-case revenue estimate ~US$400M
- Phase 2 trial not started until H1 2026, delaying human readouts
- Revenue projection (~US$400M) is contingent on demonstrated clinical efficacy
- Estimated eligible population (~98,000) assumes use at first recurrence per payer positioning
Insights
IND submission and Phase 2 plan advance IMM-529 into clinical testing with clear near-term milestones and stated commercial assumptions.
Immuron has filed an Investigational New Drug application to the FDA enabling clinical testing of IMM-529 for treatment and prevention of Clostridioides difficile infection (CDI); the company plans a Phase 2 trial in the first half of
The programme’s prospects depend on several concrete items: FDA acceptance of the IND and any associated clinical hold risks; successful initiation and enrollment of a Phase 2 study including both first-episode and recurrent CDI patients; and demonstrable efficacy on clinically meaningful endpoints. The release provides explicit metrics to monitor: an estimated eligible population of ~98,000 patients at first recurrence and a base-case annual revenue projection of
Key near-term watchpoints include FDA IND clearance, trial start and enrollment progress in H1
Key Points
- Immuron submits Investigational new drug (IND) application to FDA for clinical 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
MELBOURNE, Australia, Oct. 08, 2025 (GLOBE NEWSWIRE) -- Immuron Limited (ASX: IMC; NASDAQ: IMRN), is pleased to announce that it has submitted an Investigational New Drug (IND) application to the United States Food and Drug Administration (FDA) for clinical development of IMM-529. Under this new IND, Immuron is proposing the development of IMM-529 for treatment of Clostridioides difficile (C. diff) infection (CDI) and prevention of recurrent CDI (rCDI).
The Company plans to initiate a Phase 2 clinical trial for IMM-529 in individuals with Clostridioides difficile infection (CDI) during the first half of 2026.
Independent Market analysis conducted by Lumanity suggests that, pending demonstration of efficacy, IMM-529 could be positioned at the earliest point in the treatment algorithm permitted by payer guidelines. The Phase 2 clinical trial is expected to enroll both first episode and recurrent CDI patients. The estimated eligible population of patients would be approximately 98,000 individuals if IMM-529 is introduced as a treatment at the first recurrence stage.
Considering market size, anticipated payer dynamics, competitive landscape, and pricing assumptions, base case annual revenue potential for IMM-529 is projected at approximately US
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 treatment of CDI and prevention recurrent CDI. IMM-529 has been designed with antibodies that target the key essential virulence components of C. diff, with the potential to accelerate the clearance of CDI infection and support rapid restoration of healthy gut microbiota. This mechanism of action positions IMM-529 as a compelling oral therapeutic drug candidate for the treatment of CDI and preventative of disease recurrent CDI, addressing a critical unmet need in infectious disease management. Immuron is collaborating with Dr. Dena Lyras and her team at Monash University, Australia to develop vaccines designed to elicit antibodies against essential C. diff virulence components. IMM-529 specifically targets Toxin B (TcB), the spores, and the surface layer proteins of the vegetative cells (refer to MOA schematic - below).
This novel 3-target approach has yielded promising results in pre-clinical infection and relapse models, including (1) Prevention of primary disease (
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
Figure: Mechanism of Action of IMM-529 targeting Clostridioides difficile spores, cells and toxin B
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/0f651b8e-0c29-4151-bb9a-32be85b26697
FAQ
What did Immuron announce about IMM-529 and the FDA on October 8, 2025?
When will Immuron begin the Phase 2 trial for IMM-529 (IMRN)?
What commercial potential did Immuron cite for IMM-529 (IMRN)?
What is IMM-529’s mechanism of action for treating C. diff?
What preclinical efficacy results did Immuron report for IMM-529?
