Immuron Announces Travelan® Clinical Trial Update
Immuron (NASDAQ: IMRN) has submitted a Clinical Study Report to the FDA for its completed Travelan® (IMM-124E) Phase 2 trial, with plans to request an end of Phase 2 meeting before proceeding to Phase 3. The study demonstrated statistically significant results in both immunology and microbiome responses.
The trial showed lower IgA and IgG levels in Travelan®-treated subjects compared to placebo, indicating reduced ETEC antigen exposure. There was also a significant reduction in colony forming units in subjects' stools after 48 hours (p=0.0121), suggesting faster pathogen clearance.
Microbiome analysis revealed that the Travelan® group maintained more stable gastrointestinal microbiota, with improved richness and diversity compared to placebo. The treatment group showed increased levels of beneficial bacteria and reduced inflammation-associated bacteria.
Additionally, a separate Uniformed Services University field study has randomized 776 subjects, with final enrollments expected in March 2025 and follow-up completion around June 2025.
Immuron (NASDAQ: IMRN) ha presentato un Rapporto sullo Studio Clinico all'FDA per il suo completato trial di Fase 2 di Travelan® (IMM-124E), con l'intento di richiedere un incontro di fine Fase 2 prima di procedere alla Fase 3. Lo studio ha dimostrato risultati statisticamente significativi sia nelle risposte immunologiche che nel microbioma.
Il trial ha mostrato livelli più bassi di IgA e IgG nei soggetti trattati con Travelan®, rispetto al placebo, indicando una riduzione dell'esposizione agli antigeni ETEC. C'è stata anche una riduzione significativa delle unità formanti colonia nelle feci dei soggetti dopo 48 ore (p=0.0121), suggerendo una più rapida eliminazione dei patogeni.
L'analisi del microbioma ha rivelato che il gruppo trattato con Travelan® ha mantenuto una microbiota gastrointestinale più stabile, con una maggiore ricchezza e diversità rispetto al placebo. Il gruppo di trattamento ha mostrato livelli aumentati di batteri benefici e una riduzione dei batteri associati all'infiammazione.
Inoltre, uno studio di campo condotto dalla Uniformed Services University ha arruolato 776 soggetti, con le iscrizioni finali previste per marzo 2025 e il completamento del follow-up intorno a giugno 2025.
Immuron (NASDAQ: IMRN) ha presentado un Informe del Estudio Clínico a la FDA para su completado ensayo de Fase 2 de Travelan® (IMM-124E), con planes de solicitar una reunión de final de Fase 2 antes de proceder a la Fase 3. El estudio demostró resultados estadísticamente significativos tanto en respuestas inmunológicas como en el microbioma.
El ensayo mostró niveles más bajos de IgA e IgG en los sujetos tratados con Travelan® en comparación con el placebo, lo que indica una reducción de la exposición a los antígenos ETEC. También hubo una reducción significativa en las unidades formadoras de colonias en las heces de los sujetos después de 48 horas (p=0.0121), lo que sugiere una eliminación más rápida de patógenos.
El análisis del microbioma reveló que el grupo de Travelan® mantuvo una microbiota gastrointestinal más estable, con una mejor riqueza y diversidad en comparación con el placebo. El grupo de tratamiento mostró niveles aumentados de bacterias beneficiosas y una reducción de las bacterias asociadas con la inflamación.
Además, un estudio de campo separado de la Uniformed Services University ha aleatorizado a 776 sujetos, con las inscripciones finales esperadas para marzo de 2025 y la finalización del seguimiento alrededor de junio de 2025.
Immuron (NASDAQ: IMRN)는 완료된 Travelan® (IMM-124E) 2상 시험에 대한 임상 연구 보고서를 FDA에 제출하였으며, 3상 시험 진행 전에 2상 종료 회의를 요청할 계획입니다. 이 연구는 면역학 및 마이크로바이옴 반응 모두에서 통계적으로 유의미한 결과를 보여주었습니다.
시험 결과 Travelan® 치료를 받은 피험자에서 플라세보에 비해 IgA 및 IgG 수준이 낮아져 ETEC 항원 노출이 감소했음을 나타냅니다. 또한 48시간 후 피험자의 대변에서 집락 형성 단위가 유의미하게 감소했습니다(p=0.0121), 이는 병원균 제거가 더 빨리 이루어졌음을 시사합니다.
마이크로바이옴 분석 결과, Travelan® 그룹은 플라세보에 비해 장내 마이크로바이옴이 더 안정적이며, 풍부함과 다양성이 개선된 것으로 나타났습니다. 치료 그룹은 유익한 박테리아의 수준이 증가하고 염증과 관련된 박테리아가 감소했습니다.
또한 별도의 Uniformed Services University 현장 연구는 776명을 무작위 배정하였으며, 최종 등록은 2025년 3월에 예상되며 후속 조사는 2025년 6월경 완료될 예정입니다.
Immuron (NASDAQ: IMRN) a soumis un Rapport d'Étude Clinique à la FDA pour son essai de Phase 2 Travelan® (IMM-124E) achevé, avec des projets de demander une réunion de fin de Phase 2 avant de passer à la Phase 3. L'étude a montré des résultats statistiquement significatifs dans les réponses immunologiques et microbiomes.
L'essai a montré des niveaux d'IgA et d'IgG plus bas chez les sujets traités avec Travelan® par rapport au placebo, indiquant une exposition réduite aux antigènes ETEC. Il y a également eu une réduction significative des unités formant colonie dans les selles des sujets après 48 heures (p=0.0121), suggérant un nettoyage plus rapide des pathogènes.
L'analyse du microbiome a révélé que le groupe Travelan® maintenait une microbiote gastro-intestinale plus stable, avec une meilleure richesse et diversité par rapport au placebo. Le groupe de traitement a montré des niveaux accrus de bactéries bénéfiques et une réduction des bactéries associées à l'inflammation.
De plus, une étude de terrain distincte de l'Uniformed Services University a randomisé 776 sujets, avec des inscriptions finales attendues en mars 2025 et une finalisation du suivi prévue autour de juin 2025.
Immuron (NASDAQ: IMRN) hat einen klinischen Studienbericht an die FDA für seine abgeschlossene Travelan® (IMM-124E) Phase 2 Studie eingereicht und plant, ein Treffen zum Ende der Phase 2 anzufordern, bevor es zur Phase 3 übergeht. Die Studie demonstrierte statistisch signifikante Ergebnisse sowohl in der Immunologie als auch in den Mikrobiom-Reaktionen.
Die Studie zeigte niedrigere IgA- und IgG-Werte bei mit Travelan® behandelten Probanden im Vergleich zur Placebo-Gruppe, was auf eine reduzierte Exposition gegenüber ETEC-Antigenen hinweist. Zudem gab es nach 48 Stunden eine signifikante Reduktion der koloniebildenden Einheiten im Stuhl der Probanden (p=0.0121), was auf eine schnellere Pathogenelimination hindeutet.
Die Mikrobiom-Analyse ergab, dass die Travelan®-Gruppe eine stabilere gastrointestinalen Mikrobiota aufwies, mit verbesserter Reichhaltigkeit und Vielfalt im Vergleich zur Placebo-Gruppe. Die Behandlungsgruppe zeigte erhöhte Niveaus nützlicher Bakterien und eine Reduzierung von entzündungsassoziierten Bakterien.
Darüber hinaus hat eine separate Feldstudie der Uniformed Services University 776 Probanden randomisiert, wobei die endgültigen Einschreibungen für März 2025 erwartet werden und der Nachverfolgensabschluss voraussichtlich im Juni 2025 erfolgen wird.
- Successful completion of Phase 2 trial with statistically significant results
- Clinical data showed significant reduction in pathogen levels (p=0.0121)
- Demonstrated positive effects on gut microbiome stability and diversity
- Large-scale field study progressing well with 776 subjects enrolled
- Further investigation needed to fully understand microbiome benefits
- Phase 3 trials yet to begin, pending FDA meeting
Insights
The Phase 2 clinical trial results for Travelan® represent a significant milestone in the development pipeline. The study demonstrates statistically significant immunological responses and microbiome modulation, with key findings showing reduced IgA and IgG levels in treated subjects, indicating effective ETEC antigen binding. The p-value of 0.0121 for reduced bacterial colony counts is particularly compelling.
The microbiome data reveals improved diversity metrics and beneficial bacterial population changes, suggesting a dual mechanism of action: direct pathogen clearance and promotion of healthy gut flora. The positive impact on inflammation-associated bacteria species adds another layer of therapeutic potential. With 776 subjects enrolled in the parallel military field study, the robust sample size will provide valuable real-world efficacy data.
The submission of the Clinical Study Report to the FDA and planned end of Phase 2 meeting request signals progression toward Phase 3 trials - a critical regulatory milestone that typically precedes potential market approval.
This clinical progress positions Immuron strategically in the $1.6 billion travelers' diarrhea market. The dual-track approach - combining controlled clinical trials with a large-scale military field study - enhances the commercial potential by addressing both civilian and military markets. The microbiome findings are particularly valuable, as they align with the growing consumer interest in gut health products.
For a small-cap company (
Highlights:
- Travelan® (IMM-124E) Phase 2 Clinical Study Report submitted to the FDA
- Travelan® (IMM-124E) Phase 2 Clinical Study Statistically Significant Immunology Results
- Travelan® (IMM-124E) Phase 2 Clinical Study Statistically Significant Microbiome Responses
- Travelan® P2TD (n=866) Uniformed Services University field study randomized 776 subjects
MELBOURNE, Australia, Jan. 14, 2025 (GLOBE NEWSWIRE) -- Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and globally integrated biopharmaceutical company is pleased to announce that it has submitted the Clinical Study Report to the U.S. Food and Drug Administration (FDA) for the recently completed Phase 2 study and will soon request an end of Phase 2 meeting which is a pre-cursor to proceeding to Phase 3.
Travelan® (IMM-124E) Phase 2 Clinical Study
NCT05933525: A Randomized, Double-blind, Placebo-controlled Trial Assessing the Efficacy of IMM-124E (Travelan®) in a Controlled Human Infection Model for Enterotoxigenic Escherichia Coli (ETEC)
Immunology
Statistically significant lower levels of IgA and IgG were observed for the subjects who received Travelan® compared to those who received the placebo, which may also reflect levels of exposure to ETEC antigen. Travelan® antibodies target and bind to ETEC antigen in the gastrointestinal tract, block LPS epitopes and therefore reduce antigen exposure, resulting in lower overall IgA and IgG antibody titers.
Clinical data also demonstrated there was a statistically significant reduction in the number of colony forming units (CFUs) in the stools of subjects who received Travelan® (p =0.0121), measured 48 hours post challenge, indicating faster clearance of the challenge strain from the GI tract.
Microbiome
Participants in the Travelan® group have a more stable gastrointestinal microbiota over the treatment time period when compared with the Placebo group. Alpha diversity, a measurement of the richness (how many different species) and evenness (abundance or number of different species) revealed that the Travelan group had improved richness and Shannon diversity results compared to the Placebo group. The data indicated a difference in the richness in the diversity of certain species rather than just the abundance or number of bacterial species between the two groups.
Statistically significant differences were identified between the two treatment groups in the Beta diversity tests (number of species and abundance). The relative abundance results revealed that the Travelan group had increased levels of beneficial bacteria such as Akkermansia and Faecalibacterium. The differential abundance results confirmed increases in Agathobaculum, Slackia the Eubacterium eligens group, and the Eubacterium siraeum group; and decreases in Rumminococcus and Bacteroides. The abundance data indicates a possible link between the species of bacteria associated with reduced inflammation.
This study data implies that Travelan® appears to aid in the reduction and clearance over time of pathological ETEC bacteria, by shortening the recovery period after ETEC challenge. The mechanism indicates there is an increase in the propagation of bacteria associated with decreases in inflammation and repairing the intestinal lining. Further investigation into this association is required to fully understand the benefits of Travelan® on the gut microbiome.
Uniformed Services University field study
NCT04605783: A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate a Dietary Supplement to Maintain Gut Health During Deployment and Travel. To date a total of 776 subjects have been randomized into the clinical study. We anticipate the last enrollments to occur in March 2025 and follow-up to be completed around June 2025.
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
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
Subscribe for Immuron News: Here
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 are the key findings from IMRN's Travelan Phase 2 clinical trial?
When will IMRN complete the Uniformed Services University field study?
How many subjects are enrolled in IMRN's Uniformed Services University study?
What is the next regulatory step for IMRN's Travelan development?
What microbiome changes were observed in IMRN's Travelan trial?
