NMRC Reports Results for Campylobacter Controlled Human Infection Model Study
Immuron (ASX: IMC; NASDAQ: IMRN) announced the completion of an interim analysis by the US Naval Medical Research Command (NMRC) for a clinical trial evaluating a new oral therapeutic targeting Campylobacter and Enterotoxigenic Escherichia coli (ETEC). The trial, unrelated to Travelan®, showed 10.4% protective efficacy against moderate to severe campylobacteriosis. This result does not impact Immuron's plans for Travelan®, including the upcoming end of Phase 2 meeting with the FDA and potential Phase 3 trials in 2H 2025.
The study, funded by NMRC, involved 27 volunteers in a randomized, placebo-controlled trial. Immuron's role was to produce a hyperimmune bovine colostrum product using NMRC's campylobacter/ETEC vaccine. The findings will be presented at the 22nd International Workshop on Campylobacter, Helicobacter & Related Organisms (CHRO 2024) on October 7, 2024.
Immuron continues to collaborate with NMRC and Walter Reed Army Institute of Research (WRAIR) on developing new hyperimmune products targeting various pathogens, aiming to address the high-priority need for preventative treatments against enteric diseases in the US Military.
Immuron (ASX: IMC; NASDAQ: IMRN) ha annunciato il completamento di un'analisi intermedia da parte del Comando della Ricerca Medica Navale degli Stati Uniti (NMRC) per uno studio clinico che valuta una nuova terapia orale mirata a Campylobacter e Escherichia coli enterotossigenico (ETEC). Lo studio, non correlato a Travelan®, ha mostrato un'efficacia protettiva del 10,4% contro la campylobatteriosi da moderata a grave. Questo risultato non influisce sui piani di Immuron per Travelan®, inclusi il prossimo incontro di fine Fase 2 con la FDA e i potenziali studi di Fase 3 nel secondo semestre del 2025.
Lo studio, finanziato dal NMRC, ha coinvolto 27 volontari in un trial randomizzato, controllato con placebo. Il ruolo di Immuron è stato quello di produrre un prodotto di colostro bovino iperimmune utilizzando il vaccino campylobacter/ETEC del NMRC. I risultati saranno presentati al 22° Workshop Internazionale su Campylobacter, Helicobacter e Organismi Correlati (CHRO 2024) il 7 ottobre 2024.
Immuron continua a collaborare con NMRC e l'Istituto di Ricerca dell'Esercito Walter Reed (WRAIR) per sviluppare nuovi prodotti iperimmuni mirati a vari patogeni, con l'obiettivo di affrontare l'alta priorità della necessità di trattamenti preventivi contro le malattie enteriche per l'esercito statunitense.
Immuron (ASX: IMC; NASDAQ: IMRN) anunció la finalización de un análisis intermedio realizado por el Comando de Investigación Médica Naval de EE. UU. (NMRC) para un ensayo clínico que evalúa una nueva terapia oral dirigida a Campylobacter y Escherichia coli enterotoxigénico (ETEC). El ensayo, no relacionado con Travelan®, mostró una eficacia protectora del 10.4% contra la campylobacteriosis de moderada a grave. Este resultado no afecta los planes de Immuron para Travelan®, incluyendo la próxima reunión de fin de Fase 2 con la FDA y los potenciales ensayos de Fase 3 en la segunda mitad de 2025.
El estudio, financiado por el NMRC, involucró a 27 voluntarios en un ensayo randomizado, controlado con placebo. El papel de Immuron fue producir un producto de calostro bovino hiperinmune utilizando la vacuna de campylobacter/ETEC del NMRC. Los hallazgos se presentarán en el 22° Taller Internacional sobre Campylobacter, Helicobacter y Organismos Relacionados (CHRO 2024) el 7 de octubre de 2024.
Immuron continúa colaborando con el NMRC y el Instituto de Investigación del Ejército Walter Reed (WRAIR) en el desarrollo de nuevos productos hiperinmunes dirigidos a varios patógenos, con el objetivo de abordar la necesidad prioritaria de tratamientos preventivos contra enfermedades entéricas en el Ejército de EE. UU.
Immuron (ASX: IMC; NASDAQ: IMRN)은 미국 해군 의료 연구 사령부(NMRC)에 의해 진행된 임상 시험의 중간 분석 완료를 발표했습니다. 이 임상 시험은 Campylobacter 및 장독소성 대장균(ETEC)을 겨냥한 새로운 경구 치료제를 평가하는 것입니다. Travelan®과는 관련이 없는 이 시험은 중증 캠필로박터증에 대해 10.4%의 보호 효능을 보였습니다. 이 결과는 Immuron의 Travelan® 계획에 영향을 미치지 않으며, FDA와의 2상 시험 종료 회의 및 2025년 하반기의 3상 시험 가능성에 포함됩니다.
NMRC의 자금 지원을 받은 이 연구에는 무작위 배정된 위약 대조 시험에 27명의 자원자가 참여했습니다. Immuron의 역할은 NMRC의 Campylobacter/ETEC 백신을 사용하여 초면역 소의 초유 제품을 생산하는 것이었습니다. 이 결과는 2024년 10월 7일에 열리는 제22차 국제 Campylobacter, Helicobacter 및 관련 유기체 워크숍(CHRO 2024)에서 발표될 예정입니다.
Immuron은 NMRC 및 월터 리드 육군 연구소(WRAIR)와 협력하여 다양한 병원체를 목표로 하는 새로운 초면역 제품 개발을 계속하고 있으며, 미국 군대의 장내 질병 예방 치료에 대한 높은 우선 필요성을 해결하는 것을 목표로 하고 있습니다.
Immuron (ASX: IMC; NASDAQ: IMRN) a annoncé l'achèvement d'une analyse intermédiaire par le Commandement de Recherche Médicale Naval des États-Unis (NMRC) pour un essai clinique évaluant une nouvelle thérapie orale ciblant Campylobacter et Escherichia coli entérotoxigène (ETEC). L'essai, sans lien avec Travelan®, a montré une efficacité protectrice de 10,4 % contre la campylobactériose modérée à sévère. Ce résultat n'affecte pas les plans d'Immuron pour Travelan®, y compris la prochaine réunion de fin de Phase 2 avec la FDA et les essais de Phase 3 potentiels dans la seconde moitié de 2025.
L'étude, financée par le NMRC, a impliqué 27 volontaires dans un essai randomisé, contrôlé par placebo. Le rôle d'Immuron était de produire un produit de colostrum bovin hyperimmunisé en utilisant le vaccin Campylobacter/ETEC du NMRC. Les résultats seront présentés lors du 22ème Atelier International sur Campylobacter, Helicobacter et Organismes Associés (CHRO 2024) le 7 octobre 2024.
Immuron continue de collaborer avec le NMRC et l'Institut de Recherche de l'Armée Walter Reed (WRAIR) pour développer de nouveaux produits hyperimmunisés ciblant divers pathogènes, afin de répondre à un besoin prioritaire de traitements préventifs contre les maladies intestinales dans l'armée américaine.
Immuron (ASX: IMC; NASDAQ: IMRN) gab bekannt, dass eine Zwischenanalyse des US Naval Medical Research Command (NMRC) für eine klinische Studie zur Bewertung einer neuen oralen Therapie zur Bekämpfung von Campylobacter und enterotoxigenic E. coli (ETEC) abgeschlossen wurde. Die Studie, die nicht mit Travelan® verbunden ist, zeigte eine Schutzwirkung von 10,4 % gegen eine moderate bis schwere Campylobacteriose. Dieses Ergebnis hat keine Auswirkungen auf die Pläne von Immuron für Travelan®, einschließlich des bevorstehenden Treffens zum Ende der Phase 2 mit der FDA und potenziellen Phase-3-Studien in der zweiten Jahreshälfte 2025.
Die vom NMRC finanzierte Studie umfasste 27 Teilnehmer in einer randomisierten, placebokontrollierten Studie. Die Rolle von Immuron bestand darin, ein hyperimmunes, bovines Kolostrumprodukt mit dem Campylobacter/ETEC-Impfstoff des NMRC herzustellen. Die Ergebnisse werden am 7. Oktober 2024 auf dem 22. Internationalen Workshop zu Campylobacter, Helicobacter und verwandten Organismen (CHRO 2024) vorgestellt.
Immuron arbeitet weiterhin mit dem NMRC und dem Walter Reed Army Institute of Research (WRAIR) zusammen, um neue hyperimmune Produkte zu entwickeln, die auf verschiedene Krankheitserreger abzielen, um den hohen Bedarf an präventiven Behandlungen gegen enterale Erkrankungen im US-Militär zu decken.
- Completion of interim analysis for new oral therapeutic targeting Campylobacter and ETEC
- Ongoing collaboration with NMRC and WRAIR for developing new hyperimmune products
- Travelan® Phase 3 clinical trials planned for 2H 2025
- Uniformed Services University clinical study of Travelan® (n=866) is 85% recruited with topline results expected in April 2025
- Low protective efficacy (10.4%) of the new oral therapeutic against moderate to severe campylobacteriosis
- Results of the NMRC trial are unrelated to and do not support Travelan®'s development
Insights
The results of the NMRC study on the new oral therapeutic for Campylobacter and ETEC show efficacy, with only
However, it's important to note that this study does not impact Immuron's plans for Travelan®, including the upcoming Phase 3 trials and commercialization strategy. The ongoing Uniformed Services University clinical study of Travelan® (n=866) is
The NMRC's continued collaboration with Immuron to develop new hyperimmune products targeting various pathogens, backed by U.S. Department of Defense funding, presents potential future revenue streams. This ongoing partnership with military research institutions underscores the strategic importance of Immuron's technology in addressing military health concerns.
While the CampETEC study results are disappointing, they highlight the complexity of developing effective treatments for enteric diseases. The lower efficacy compared to Travelan® suggests that the conjugated vaccine approach for Campylobacter and ETEC may not be as effective as initially hoped.
However, the ongoing development of new vaccines for campylobacter, shigella and different E. coli strains presents opportunities for Immuron. The company's expertise in producing hyperimmune bovine colostrum products positions it well to collaborate on these new initiatives.
The recognition of post-infectious sequelae from traveler's diarrhea, including irritable bowel syndrome and autoimmune diseases, emphasizes the importance of preventative treatments. This could potentially increase the value proposition of Immuron's products in both military and civilian markets, especially given the growing antibiotic resistance among enteric pathogens.
MELBOURNE, Australia, Oct. 04, 2024 (GLOBE NEWSWIRE) -- Immuron Limited (ASX: IMC; NASDAQ: IMRN), is an Australian based and globally integrated biopharmaceutical company that has developed two commercially available oral immunotherapeutic products for the treatment of gut mediated diseases. Following discussion with the US Naval Medical Research Command (NMRC), today the Company can announce that the NMRC has completed the interim analysis for the clinical evaluation of a new oral therapeutic targeting Campylobacter and Enterotoxigenic Escherichia coli (ETEC).
The results of this clinical trial are unrelated to Travelan® and do not impact Immuron’s plans to hold an end of Phase 2 meeting with the U.S. Food and Drug Administration (FDA) with a view to initiating Phase 3 clinical trial(s) of Travelan® in 2H 2025. Nor does this NMRC trial impact on Immuron’s commercialization strategy for Travelan®. This commercialization strategy also includes the results of the Uniformed Services University clinical study (n=866) of Travelan® which is
The details of the trial are available at clinicaltrials.gov/study/NCT06122870 . The trial was funded by the NMRC. Immuron’s involvement in the study was to produce a hyperimmune bovine colostrum product using the NMRC developed campylobacter/ETEC vaccine which was tested in a controlled human infection model study.
Campylobacter jejuni is among the most common causes of diarrheal disease worldwide. Relatively little is known regarding what constitutes protective immunity against Campylobacter and there is currently no licensed vaccine to prevent disease caused by C. jejuni. C. jejuni is considered an invasive enteric pathogen, but the molecular details of its pathogenesis remain difficult to interpret or understand largely due to the lack of reliable, non-primate animal models of disease. To address this unmet medical need, the NMRC developed a conjugated vaccine using the Campylobacter jejuni capsule crosslinked to the colonization factor antigen 1 (CFA/1) of Enterotoxigenic Escherichia coli (ETEC). These key antigenic targets are predicted to be protective against diarrhea induced by both pathogens. Immuron used the conjugated vaccine to produce a new hyperimmune anti-microbial for clinical evaluation by the NMRC. The NMRC confirmed that the conjugated vaccine produced a robust immunological response in cows and reported that the new Hyper-immune therapeutic contains high levels of antibodies which specifically target Campylobacter jejuni capsule and CFA/1 (ASX Announcement 9 November 2020).
Immuron has been advised by NMRC that the safety and protective efficacy of the product was tested in a controlled human infection-model clinical trial focusing on the ability of the hyperimmune product to protect volunteers against moderate to severe campylobacteriosis. A total of 27 volunteers were enrolled in the randomized, placebo-controlled trial and randomly assigned to either the active or placebo arm of the study. The interim results demonstrated
Dr Frédéric Poly, the principal Investigator of the study, will present the findings for the NMRC CampETEC clinical study at the 22nd International Workshop on Campylobacter, Helicobacter & Related Organisms (CHRO 2024) which commences on 7 October 2024 at the Perth Convention and Exhibition Centre. A copy of the presentation will be made available on the Company website once it is made available to the Company.
Travelan® demonstrated clinical efficacy in preventing ETEC-attributable diarrhea in two previous CHIM studies. These studies showed dosing 400 mg three times daily, resulted in
The vaccine used in CampETEC was a conjugated vaccine for both campylobacter and ETEC. The NMRC recently received U.S. Department of Defense funding to develop a new campylobacter vaccine not conjugated with ETEC as well as new vaccines for shigella and different strains of E.coli. The plan is to develop new hyperimmune products which specifically target each of these pathogens in collaboration with Immuron. NRMC and Walter Reed Army Institute of Research (WRAIR) are now developing an enhanced formulation of Travelan potentially expanding the coverage of the product as a therapeutic measure against endemic military relevant diarrheal pathogens (ASX announcement 16 August 2024).
Infectious diarrhea is the most common illness reported by travelers visiting developing countries and among US troops deployed overseas. The morbidity and associated discomfort stemming from diarrhea decreases daily performance, affects judgment, decreases morale and declines operational readiness. The first line of treatment for infectious diarrhea is the prescription of antibiotics. Unfortunately, in the last decade, several enteric pathogens have had an increasing resistance to commonly prescribed antibiotics. In addition, traveler’s diarrhea is now recognized by the medical community to result in post-infectious sequelae, including post-infectious irritable bowel syndrome and several post-infectious autoimmune diseases. A preventative treatment that protects against enteric diseases is a high priority objective for the US Military.
This release has been authorized by the directors of Immuron Limited.
COMPANY CONTACT:
Steven Lydeamore
Chief Executive Officer
Ph: +61 (0)3 9824 5254
steve@immuron.com
About Travelan®
Travelan® is an orally administered passive immunotherapy that prophylactically reduces the likelihood of contracting traveler’s diarrhea, a digestive tract disorder that is commonly caused by pathogenic bacteria and the toxins they produce. Travelan® is a highly purified tableted preparation of hyperimmune bovine antibodies and other factors, which when taken with meals bind to diarrhea-causing bacteria and prevent colonization and the pathology associated with traveler’s 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 Traveler’s Diarrhea, reduce the risk of minor gastrointestinal disorders and is antimicrobial. In Canada, Travelan® is a licensed natural health product (NPN 80046016) and is indicated to reduce the risk of Traveler’s Diarrhea. In the U.S., Travelan® is sold as a dietary supplement for digestive tract protection.
About Traveler’s Diarrhea
Traveler’s Diarrhea is a gastrointestinal infection with symptoms that include loose, watery (and occasionally bloody) stools, abdominal cramping, bloating, and fever, Enteropathogenic bacteria are responsible for most cases, with enterotoxigenic Escherichia coli (ETEC) playing a dominant causative role. Campylobacter spp. are also responsible for a significant proportion of cases. The more serious infections with Salmonella spp. the bacillary dysentery organisms belonging to Shigella spp. and Vibrio spp. (the causative agent of cholera) are often confused with Traveler’s Diarrhea as they may be contracted while travelling and initial symptoms are often indistinguishable.
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.
For more information visit: http://www.immuron.com
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 was the protective efficacy of Immuron's new oral therapeutic in the NMRC trial?
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