Immuron IMM-529 IND approved by FDA
Immuron (NASDAQ:IMRN) announced that the U.S. Food and Drug Administration has approved its Investigational New Drug application for IMM-529 (IND 032095), enabling a Phase 2 randomized, double-blind, placebo-controlled trial in CDI patients to proceed.
The study will enroll up to 60 subjects in a 2:1 IMM-529+SOC versus placebo+SOC design across multiple Australian sites, with first-half 2026 start planned. Primary objectives are safety and tolerability; efficacy will be measured by mortality, symptom scores and recurrence.
Immuron cites preclinical results (prevention 80%; recurrence protection 67%; treatment 78.6%) and projects a base-case yearly revenue of US$400M if positioned at first recurrence, noting anticipated payer restrictions and oral dosing as a favorable attribute.
Immuron (NASDAQ:IMRN) ha annunciato che la Food and Drug Administration statunitense ha approvato la sua domanda IND per IMM-529 (IND 032095), consentendo il proseguimento di uno studio di fase 2 randomizzato, in doppio cieco e controllato con placebo nei pazienti con CDI.
Lo studio prevede l'inclusione di fino a 60 soggetti in un disegno 2:1 IMM-529+SOC contro placebo+SOC su più siti in Australia, con l'inizio previsto nella prima metà del 2026. Gli obiettivi primari sono sicurezza e tollerabilità; l'efficacia sarà misurata in base alla mortalità, ai punteggi dei sintomi e alla ricorrenza.
Immuron cita risultati preclinici (prevenzione 80%; protezione contro la recidiva 67%; trattamento 78,6%) e proietta un valore di base annuo di US$400M se posizionato al primo ricorrenza, osservando restrizioni previste dai payer e l'assunzione orale come attributo favorevole.
Immuron (NASDAQ:IMRN) anunció que la Administración de Alimentos y Medicamentos de EE. UU. ha aprobado su solicitud de Investigational New Drug para IMM-529 (IND 032095), lo que permite que progrese un ensayo aleatorizado, doble ciego, controlado con placebo de fase 2 en pacientes con CDI.
El estudio incluirá hasta 60 sujetos en un diseño 2:1 IMM-529+SOC frente a placebo+SOC en varios sitios australianos, con inicio previsto para la primera mitad de 2026. Los objetivos primarios son seguridad y tolerabilidad; la eficacia se medirá por mortalidad, puntuaciones de síntomas y recurrencia.
Immuron cita resultados preclínicos (prevención 80%; protección contra recurrencia 67%; tratamiento 78.6%) y proyecta un ingreso anual base de US$400M si se posiciona en la primera recurrencia, destacando restricciones previstas por parte de los pagadores y la dosificación oral como atributo favorable.
Immuron (NASDAQ:IMRN)는 미국 식품의약국(FDA)이 IMM-529 (IND 032095)에 대한 Investigational New Drug 신청을 승인하여 CDI 환자에서 단계 2 무작위, 이중 맹검, 위약 대조 연구를 진행할 수 있게 되었다고 발표했다.
연구는 호주 여러 site에서 60명의 피험자를 2:1 IMM-529+SOC 대 위약+SOC 설계로 모집하며, 2026년 상반기에 시작할 계획이다. 주요 목표는 안전성 및 내약성; 효과는 사망률, 증상 점수 및 재발로 평가된다.
Immuron은 전임상 결과(예방 80%; 재발 방지 67%; 치료 78.6%)를 인용하며, 최초 재발 시 위치했을 경우 연간 기본 매출이 미화 4억 달러 수준으로 예상되며, 지불자 제약과 경구 투여를 호의적 특성으로 지적한다.
Immuron (NASDAQ:IMRN) a annoncé que la Food and Drug Administration américaine a approuvé sa demande IND (Investigational New Drug) pour IMM-529 (IND 032095), permettant le démarrage d'un essai randomisé, en double aveugle et contrôlé par placebo de phase 2 chez des patients atteints de CDI.
L'étude recruteront jusqu'à 60 sujets selon un design 2:1 IMM-529+SOC contre placebo+SOC sur plusieurs sites australiens, avec un démarrage prévu au premier semestre 2026. Les objectifs primaires sont la sécurité et la tolérance; l'efficacité sera mesurée par la mortalité, les scores de symptômes et la récurrence.
Immuron cite des résultats précliniques (prévention 80%; protection contre les récidives 67%; traitement 78,6%) et prévoit un chiffre d'affaires annuel de référence de US$400M s'il est positionné dès la première récidive, en notant les restrictions attendues des assureurs et la posologie orale comme un attribut favorable.
Immuron (NASDAQ:IMRN) gab bekannt, dass die U.S. Food and Drug Administration seine IND-Anmeldung für IMM-529 (IND 032095) genehmigt hat, wodurch eine randomisierte, doppelblinde, placebokontrollierte Phase-2-Studie bei CDI-Patienten fortgesetzt werden kann.
Die Studie wird bis zu 60 Probanden in einem 2:1-Verhältnis IMM-529+SOC gegen Placebo+SOC an mehreren australischen Standorten einschließen, mit geplantem Start in der ersten Hälfte 2026. Primäre Ziele sind Sicherheit und Verträglichkeit; Wirksamkeit wird anhand von Mortalität, Symptomwerten und Rezidiv gemessen.
Immuron verweist auf präklinische Ergebnisse (Prävention 80%; Rezidivschutz 67%; Behandlung 78,6%) und prognostiziert einen Basisjahresumsatz von US$400M, wenn es beim ersten Rezidiv positioniert wird, wobei erwartete Kostenträgerbeschränkungen und orale Verabreichung als vorteilhaftes Merkmal genannt werden.
Immuron (NASDAQ:IMRN) أعلنت أن إدارة الغذاء والدواء الأميركية وافقت على طلبها للدواء التجريبي الجديد لـ IMM-529 (IND 032095)، مما يتيح متابعة تجربة عشوائية في المرحلة الثانية، مزدوجة التعمية، محكومة بالدليل الوهمي في مرضى CDI.
ستشمل الدراسة حتى 60 مشاركاً بتصميم 2:1 IMM-529+SOC مقابل placebo+SOC عبر عدة مواقع في أستراليا، مع بدء مخطط في النصف الأول من 2026. الأهداف الأساسية هي السلامة والتحمل؛ ستتم قياس الفعالية من خلال الوفيات، درجات الأعراض والتكرار.
تشير Immuron إلى نتائج قبل السريرية (الوقاية 80%; الحماية من الانتكاس 67%; العلاج 78.6%) وتخطّط لإيراد سنوي أساسي قدره US$400M إذا تم وضعه في أول تكرار، مع الإشارة إلى القيود المتوقعة من الجهات الدافعة وميزة الجرعات الفموية.
- FDA IND approval granted for IMM-529 (IND 032095)
- Phase 2 start planned for H1 2026
- Planned randomized double-blind 60-subject study (2:1 ratio)
- Preclinical protection: Prevention 80%, Recurrence protection 67%, Treatment 78.6%
- Company projects US$400M annual base-case revenue if positioned at first recurrence
- Oral dosing viewed positively by infectious disease experts
- Planned Phase 2 sample of up to 60 subjects may limit statistical power for efficacy endpoints
- Company notes anticipated payer restrictions that could limit market access and uptake
Insights
FDA cleared the IMM-529 IND, enabling a Phase 2 randomized placebo‑controlled study to start in H1
IMM-529 now has an active FDA IND (032095) allowing a Phase 2 trial of up to 60 subjects in Australia to test oral bovine colostrum‑derived antibodies as adjunctive therapy with standard of care for Clostridioides difficile infection (CDI). The plan targets both first‑episode and recurrent CDI, with subjects randomized 2:1 (IMM‑529+SOC vs placebo+SOC). The primary objective is safety and tolerability; efficacy will be measured by mortality, symptoms and recurrence rate.
The program’s strengths include an oral route, a three‑target antibody approach (Toxin B, spores, surface layer proteins), and preclinical signals showing prevention and treatment effects (preclinical results:
Watch near‑term milestones: trial initiation in H1
Key Points
- Immuron receives U.S. Food and Drug administration (FDA) approval for IMM-529 Investigational New Drug (IND) application and clinical study may proceed
- FDA assigned an IND number (032095) for the IMM-529 application
- IND 32095 is Immuron’s Investigational new drug (IND) application for clinical development of IMM-529 as product to specifically prevent or treat Clostridioides difficile infection (CDI) and is now active
MELBOURNE, Australia, Nov. 05, 2025 (GLOBE NEWSWIRE) -- Immuron Limited (ASX: IMC; NASDAQ: IMRN), is pleased to announce that the United States Food and Drug Administration (FDA) has approved Immuron’s Investigational New Drug application for IMM-529 and the Phase 2 clinical trial may proceed.
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.
The Phase 2 clinical trial will be a randomized, double blind, placebo-controlled clinical study of IMM-529 with Standard of Care (SOC) for the treatment of CDI in subjects with first episode CDI or recurrent CDI. Up to 60 subjects will be enrolled in the study. Subjects will be randomly assigned to IMM-529 + SOC or placebo + SOC in a 2:1 ratio at multiple sites in Australia. The primary objective will be to evaluate the safety and tolerability of IMM-529 together with SOC in patients with CDI or recurrent CDI. Determination of efficacy will be assessed by the measurement and comparison of mortality rate, disease symptoms and recurrence rate for each treatment group.
Opportunity assessment by Lumanity indicates that if efficacious, IMM-529 will be positioned as early in treatment algorithm as payers will allow. It is anticipated that first-episode and recurrent patients will be recruited in the IMM-529 Phase 2 clinical trial design. Up to ~98k patients would be eligible if IMM-529 is 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
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 (
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
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/b49e931f-7790-48ed-9963-fae315626e3a
FAQ
What did Immuron announce about IMM-529 on November 5, 2025 (IMRN)?
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