Immuron Announces Clinical Trial Update
Immuron (NASDAQ: IMRN) provided a clinical update on IMM-529 and Travelan on Oct 31, 2025. The company said its IMM-529 IND for Clostridioides difficile has been acknowledged by FDA CBER with an assigned biologic name and IND number, and is under active review after an Oct 25, 2025 FDA request for additional clinical information. Immuron submitted a comprehensive reply and made minor protocol updates ahead of the 30-day decision date.
The Uniformed Services University Travelan P2TD study (n=851) topline results were delayed from end-Oct to end-Nov 2025 due to a U.S. government shutdown; those results will inform End-of-Phase 2 dosing (twice-daily vs three-times-daily).
Immuron (NASDQ: IMRN) ha fornito un aggiornamento clinico su IMM-529 e Travelan il 31 ottobre 2025. L'azienda ha dichiarato che l'IND di IMM-529 per Clostridioides difficile è stato riconosciuto dalla FDA CBER con un nome biologico assegnato e un numero IND, ed è in revisione attiva dopo la richiesta della FDA del 25 ottobre 2025 di ulteriori informazioni cliniche. Immuron ha presentato una risposta completa e ha apportato lievi aggiornamenti al protocollo prima della data di decisione di 30 giorni.
Lo studio Travelan P2TD dell'Uniformed Services University (n=851) ha ritardato i risultati principali da fine ottobre a fine novembre 2025 a causa di una chiusura del governo degli Stati Uniti; tali risultati informeranno la somministrazione End-of-Phase 2 (due volte al giorno vs tre volte al giorno).
Immuron (NASDAQ: IMRN) proporcionó una actualización clínica sobre IMM-529 y Travelan el 31 de octubre de 2025. La empresa dijo que su IND de IMM-529 para Clostridioides difficile ha sido reconocido por la FDA CBER con un nombre biológico asignado y un número IND, y está bajo revisión activa tras una solicitud de la FDA el 25 de octubre de 2025 de información clínica adicional. Immuron presentó una respuesta integral y realizó ligeras actualizaciones del protocolo antes de la fecha de decisión de 30 días.
El estudio Travelan P2TD de la Uniformed Services University (n=851) obtuvo retrasos en sus resultados principales desde finales de octubre hasta finales de noviembre de 2025 debido a un cierre del gobierno de EE. UU.; esos resultados informarán la dosificación End-of-Phase 2 (dos veces al día frente a tres veces al día).
Immuron (NASDAQ: IMRN)는 2025년 10월 31일 IMM-529와 Travelan에 대한 임상 업데이트를 제공했습니다. 회사는 Clostridioides difficile용 IMM-529 IND가 FDA CBER에 의해 생물학적 명칭이 배정된 IND 번호와 함께 인정되었으며, 2025년 10월 25일 추가 임상 정보 요청 이후 활성 심사가 진행 중이라고 밝혔습니다. Immuron은 포괄적인 답장을 제출했고 30일 결정 기한 전에 프로토콜에 경미한 업데이트를 했습니다.
Uniformed Services University Travelan P2TD 연구(n=851)의 주요 결과는 미국 정부의 셧다운으로 10월 말에서 11월 말로 연기되었습니다. 이 결과는 End-of-Phase 2 용량 조정(하루 두 번 대 세 번)을 정보로 제공할 예정입니다.
Immuron (NASDAQ: IMRN) a fourni une mise à jour clinique sur IMM-529 et Travelan le 31 octobre 2025. La société a déclaré que son IND IMM-529 pour Clostridioides difficile a été reconnu par la FDA CBER avec un nom biologique attribué et un numéro IND, et est en cours d’examen actif après une demande de la FDA du 25 octobre 2025 pour des informations cliniques supplémentaires. Immuron a soumis une réponse complète et a apporté de légères mises à jour du protocole avant la date de décision sous 30 jours.
L’étude Travelan P2TD de l’Uniformed Services University (n=851) voit ses résultats préliminaires retardés de fin octobre à fin novembre 2025 en raison d'une fermeture du gouvernement américain; ces résultats éclaireront le dosage End-of-Phase 2 (deux fois par jour vs trois fois par jour).
Immuron (NASDAQ: IMRN) gab am 31. Oktober 2025 ein klinisches Update zu IMM-529 und Travelan. Das Unternehmen sagte, dass sein IMM-529 IND für Clostridioides difficile von der FDA CBER mit einem zugewiesenen biologischen Namen und IND-Nummer anerkannt wurde und sich nach einer Aufforderung der FDA vom 25. Oktober 2025 nach zusätzlichen klinischen Informationen in der aktiven Prüfung befindet. Immuron hat eine umfassende Antwort eingereicht und vor dem 30-Tage-Entscheidungstermin kleinere Protokollaktualisierungen vorgenommen.
Die Uniformed Services University Travelan P2TD-Studie (n=851) verzögerte die Topline-Ergebnisse von Ende Okt auf Ende Nov 2025 aufgrund eines US-Regierungsstillstands; diese Ergebnisse werden die End-of-Phase-2-Dosierung (zweimal täglich vs dreimal täglich) informieren.
Immuron (NASDAQ: IMRN) قدمت تحديثًا سريريًا حول IMM-529 و Travelan في 31 أكتوبر 2025. قالت الشركة إن IND IMM-529 الخاص بـ Clostridioides difficile قد تم الاعتراف به من قِبل FDA CBER مع اسم بيولوجي معين ورقم IND، وهو قيد المراجعة النشطة بعد طلب FDA في 25 أكتوبر 2025 للحصول على معلومات سريرية إضافية. قدمت Immuron ردًا شاملاً وأجرت تحديثات طفيفة على البروتوكول قبل تاريخ القرار خلال 30 يومًا.
دراسة Travelan P2TD في Uniformed Services University (المشاركون n=851) تأخرت نتائجها الأساسية من نهاية أكتوبر إلى نهاية نوفمبر 2025 بسبب إغلاق حكومي أمريكي؛ ستوجه هذه النتائج جرعة End-of-Phase 2 (مرتين في اليوم مقابل ثلاث مرات في اليوم).
- IMM-529 IND acknowledged by FDA CBER with assigned IND number (Oct 2025)
- Company submitted comprehensive FDA response and protocol updates before IND 30-day decision
- Travelan P2TD study enrolled n=851 and topline data expected end-November 2025
- FDA issued a request for additional clinical information (Oct 25, 2025), potentially delaying IND progress
- Uniformed Services University topline results delayed from end-October to end-November 2025 due to U.S. government shutdown
Insights
IND under active FDA review and a delayed Travelan® topline readout; program progress but no definitive efficacy or regulatory outcomes yet.
Immuron made procedural progress: the IMM-529 IND received a biologic name and IND number and is "under active review" by the FDA, and the company submitted a substantive response plus minor protocol amendments ahead of the IND 30-day decision date. These steps advance the administrative regulatory pathway for IMM-529 and preserve the company’s ability to start clinical work if the IND remains open.
The main dependencies are clear: the FDA’s review outcome and the Uniformed Services University topline report now expected end of
Watch items and near-term timing: the FDA 30-day decision following the company’s reply to the IND questions and the Uniformed Services University topline readout by end of
- IMM-529 IND: currently under review, FDA request for Information – minor updates to clinical protocol completed and submitted
- Travelan® P2TD (n=851) Uniformed Services University study topline data delayed to the end of November due to U.S government shutdown
MELBOURNE, Australia, Oct. 31, 2025 (GLOBE NEWSWIRE) -- Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and globally integrated biopharmaceutical company provides a clinical trial update on Travelan® and IMM-529.
IMM-529 IND (Clostridioides difficile infection)
Immuron announced on October 8, 2025 submission of an Investigational New Drug (IND) application to the United States Food and Drug Administration (FDA) for the clinical development of IMM-529 to prevent or treat Clostridioides difficile Infection.
Immuron has received formal acknowledgment of its Investigational New Drug (IND) application from the Center for Biologics Evaluation and Research (CBER), including assignment of a biologic product name and IND number. On October 25th, the U.S. Food and Drug Administration (FDA) informed the company that the IND is currently under active review and issued a request for additional clinical information. In response, Immuron submitted a comprehensive reply addressing the FDA’s queries and made minor updates to the clinical trial protocol to incorporate the agency’s recommendations ahead of the IND 30-day decision date.
Travelan® Uniformed Services University P2TD study (Incidence of gut health deficiencies)
Immuron was expecting the Uniformed Services University to provide topline results from this study by the end of October 2025. Due to delays associated with government shutdown, results are now not expected until the end of November 2025.
Travelan® end of Phase 2 meeting with the FDA
The results of the P2TD clinical study, conducted by the Uniformed Services University, will play a pivotal role in shaping Immuron’s dosing strategy for its upcoming End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA). Should the study demonstrate favorable outcomes, Immuron intends to propose a twice-daily dosing regimen. However, if the data do not show superiority over previous findings associated with a three-times-daily regimen, the company will consider maintaining the existing three-times-daily dosing recommendation.
Background on Travelan® Clinical Trials
Immuron has conducted multiple Travelan® clinical trials which are summarized in the Table below. It is important to note that dosing in the Uniformed Services University P2TD study (NCT04605783) is Travelan® or Placebo (600mg) taken as 1 sachet twice daily with meals. The dosage form and administration is different than our commercial product, Travelan®, directions for use are to take one to two caplets before each meal (i.e. three times daily). Immuron recently completed a Travelan® Phase 2 clinical trial (NCT05933525) during which 6 caplets (1200mg) were taken once daily.
| Travelan® ETEC Challenge Studies (double-blind placebo controlled) | ||
| 1 | 30 subjects received 400mg Travelan/placebo 3x daily Diarrhea attack rate = | Travelan provided:
|
| 2 | 60 subjects received 200 - 400mg Travelan/placebo 3x daily Diarrhea attack rate = | Travelan provided:
|
| 3 | 60 subjects received 1200mg Travelan/Placebo 1x daily Diarrhea attack rate = Cohort 1 (n=26) attack rate1 = | Travelan provided:
|
| IMM-124E Non-Challenge Field Study (double-blind placebo controlled) | ||
| 4 | 868 subjects received 600mg Travelan/Placebo 2x daily Diarrhea attack rate = | Results TBC |
| Clinical trial 1 and 2 published in Otto et al., 2011. Clinical trial 3 recently completed once daily dosing Clinical trial 4 USU study. *Statistically significant; 1 range covers all diarrhea to severe diarrhea cases; 2 For the USU study the formulation is a powdered-form of Travelan also known as IMM-124E, which is the active component of Travelan®. | ||
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.
About Travelan®
Travelan® is an orally administered passive immunotherapy that prophylactically reduces the likelihood of contracting travelers’ diarrhea, a digestive tract disorder that is commonly caused by pathogenic bacteria and the toxins they produce. Travelan® is a highly purified tabletized preparation of hyper immune bovine antibodies and other factors, which when taken with meals bind to diarrhea-causing bacteria and prevent colonization and the pathology associated with travelers’ diarrhea. In Australia, Travelan® is a listed medicine on the Australian Register for Therapeutic Goods (AUST L 106709) and is indicated to reduce the risk of Travelers’ Diarrhea, reduce the risk of minor gastro-intestinal disorders and is antimicrobial. In Canada, Travelan® is a licensed natural health product (NPN 80046016) and is indicated to reduce the risk of Travelers’ Diarrhea. In the U.S., Travelan® is sold as a dietary supplement for digestive tract protection.
Travelers’ diarrhea (TD)
TD is generally defined as the passage of ≥ 3 unformed stools per 24 hours plus at least one additional symptom (such as nausea, vomiting, abdominal cramps, fever, blood/mucus in the stools, or fecal urgency) that develop while abroad or within 10 days of returning from any resource-limited destinations (Leung et al., 2006). Diarrhea continues to be the most frequent health problem among travelers to destinations in lower- and middle-income regions (Steffen, 2017). Deployed US military personnel, essentially representing a long-term traveller population, are particularly affected given their population dynamics and the context in which they seek care and treatment (Connor et al., 2012). Diarrhea is the leading infectious disease threat to the overall health and preparedness of deployed US armed forces, with diarrheagenic E. coli, Campylobacter spp., and Shigella spp. among the most commonly reported etiologies (Riddle et al., 2006).
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.
IMM-124E (Travelan®)
IMM-124E was developed using Immuron’s platform technology. IMM-124E is produced from the colostrum of birthing cattle that have been immunised during pregnancy with a vaccine containing the outer antigens of multiple human derived ETEC. A total of 13 ETEC strains are used in the vaccine to produce high levels of antibodies against selected surface antigens from the most common strains of ETEC.
The resultant hyperimmune colostrum IMM-124E from ETEC vaccinated cows contains significant levels of polyclonal antibodies specific for ETEC antigens LPS, CFA-I and Flagellin (Sears et al., 2017).
The antibodies produced in IMM-124E have been found to have a stronger binding and neutralizing activity (than the antibodies of unvaccinated cattle) against a wide range of LPS antigens including both the variable O-polysaccharide region and the preserved oligosaccharide core ‘R’ region of LPS from the 13 serotypes used in the ETEC vaccine.
IMM-124E is manufactured into a tablet form referred to as Travelan®.
IMM-529
Immuron is developing IMM-529 as an adjunctive therapy in combination with standard of care antibiotics for the prevention and/or treatment of recurrent Clostridioides difficile infection (CDI). IMM-529 antibodies targeting Clostridioides difficile (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.
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 (Hutton et al., 2017).
References
Connor P, Porter CK, Swierczewski B and Riddle MS. Diarrhea during military deployment: current concepts and future directions. Curr Opin Infect Dis. 25(5): 546-54; 2012.
Hutton, M.L., Cunningham, B.A., Mackin, K.E. et al. Bovine antibodies targeting primary and recurrent Clostridium difficile disease are a potent antibiotic alternative. Sci Rep 7, 3665 (2017). https://doi.org/10.1038/s41598-017-03982-5
Leung AK, Robson WL, Davies HD. Travelers’ diarrhea. Adv Ther. Jul-Aug; 23(4): 519-27; 2006
Otto W, Najnigier B, Stelmasiak T and Robins-Browne RM. Randomized control trials using a tablet formulation of hyperimmune bovine colostrum to prevent diarrhea caused by enterotoxigenic Escherichia coli in volunteers Scandinavian Journal of Gastroenterology 46: 862– 868; 2011.
Riddle MS, Sanders JW, Putnam SD, and Tribble DR. Incidence, etiology, and impact of diarrhea among long-term travelers’ (US military and similar populations): A systematic review. American Journal of Tropical Medicine and Hygiene. 74(5): 891-900; 2006.
Sears KT, Tennant SM, Reymann MK, Simon R, Konstantopolos N, Blackwelder WC, Barry EM and Pasetti MF. Bioactive Immune Components of Anti-Diarrheagenic Enterotoxigenic Escherichia coli Hyperimmune Bovine Colostrum products. Clinical and Vaccine Immunology. 24 (8) 1-14; 2017.
Steffen R. Epidemiology of travelers' diarrhea. J Travel Med. 24(suppl_1): S2-S5; 2017.
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.
FAQ
What is the current FDA status of Immuron's IMM-529 (NASDAQ: IMRN) IND as of Oct 2025?
When will Immuron (IMRN) receive topline results from the Travelan Uniformed Services University P2TD study?
How will the Travelan P2TD (NCT04605783) results affect Immuron's dosing plan for FDA End-of-Phase 2?
What protocol actions did Immuron take after FDA feedback on IMM-529?
What is the difference between the Travelan P2TD study formulation and commercial Travelan directions?
Does the Oct 31, 2025 update include any new efficacy readouts for Travelan?
