US Department of Defense Uniformed Services University Clinical Evaluation of Travelan™
Immuron Limited (ASX: IMC; NASDAQ: IMRN) provides an update on its clinical trial evaluating the efficacy of Travelan® against two non-antibiotic products for Travelers’ Diarrhea (TD). Manufacture of investigational medical products is complete, and initial shipments have been dispatched. The clinical protocol has been amended to extend the treatment period from 13 to 22 days due to COVID-19 quarantine requirements. Planned enrollment of 1,336 participants is expected to begin in June 2022, with completion anticipated within 18 months.
- Completion of investigational product manufacture, enabling clinical trials.
- Initial shipments sent to trial sites, indicating progress.
- Extended treatment duration may improve outcomes for travelers under COVID-19 restrictions.
- Recruitment expected to take 18 months, delaying potential product availability.
- Dependence on ethics board approval may introduce uncertainty in timelines.
UPDATE
Key Points
- Manufacture Completed of investigational medical products to be clinically evaluated by the Uniformed Services University (USU). The clinical program aims to determine the comparative efficacy of Travelan® with two third party non-antibiotic OTC products in Travelers’ Diarrhea
- The treatment period in the clinical protocol has been extended from 13 days to 22 days, to accommodate COVID-19 quarantine period requirements during travel
- Initial shipments of investigational medicinal products to clinical trial sites now dispatched
- USU are anticipating an enrolment start date of June 2022 and plan to enrol 1336 participants in total
MELBOURNE, Australia, May 09, 2022 (GLOBE NEWSWIRE) -- Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian biopharmaceutical company focused on developing and commercializing oral immunotherapeutic products for the prevention and treatment of gut pathogens, today is pleased to provide shareholders and the market with a progress update on the planned clinical trial to evaluate the efficacy of Travelan® and two third party non-antibiotic products in Travelers’ Diarrhea
USU’s Infectious Diseases Clinical Research Program (IDCRP), the UK Ministry of Defense and the New York City Travel Clinic are jointly planning to conduct the randomized clinical trial to evaluate the efficacy of three commercially available nutraceutical products for TD and inform strategies for Defense Force Health Protection. The P4TD study is a randomized, double-blind, placebo controlled multicenter clinical trial designed to evaluate the effectiveness of 3 nutraceuticals: A prebiotic (Bimuno®), a probiotic (Florastor®) and IMM-124E (Travelan®) passive immunoprophylaxis verses a placebo, for prophylaxis during deployment or travel to a high-TD risk region (ClinicalTrials.gov Identifier: NCT04605783)All study participants (1336 in total) will be randomized to one of the three active products or placebo (334 per arm).
USU have completed the manufacture of the first batches of investigational medicinal products and shipment of these to the first clinical trial sites is now complete. USU are anticipating recruitment of study participants to commence in June 2022 and expect to complete clinical trial enrolment in approximately 18 months.
The clinical protocol has also been amended to extend the treatment period from 13 days to 22 days to cover the COVID-19 quarantine period still required by some countries. The extended time is necessary as those travelers required to quarantine upon arrival who may be still at risk of diarrhea symptoms during this period. The protocol amendment has now been submitted to the ethics board for approval and recruitment will commence once approval has been granted.
The Problem: Travelers’ diarrhea (TD) remains a highly prevalent disease that impacts operational readiness of military personnel and is also debilitating civilian travel. In addition to its acute morbidity, TD is associated with acquisition of antimicrobial resistance genes and long-term sequelae. Current mitigation strategies including pre-travel counseling and antibiotics for prevention and treatment have important limitations, and there are currently no licensed, pathogen-specific vaccines for TD prevention.
The Approach: Prebiotics, probiotics and passive immunotherapy may offer safe and relatively inexpensive preventive strategies by promoting gut resistance to enteropathogens, and potentially lessening the use of antibiotics. USU’s Infectious Diseases Clinical Research Program (IDCRP), the UK Ministry of Defense and the New York City Travel Clinic are jointly conducting a randomized clinical trial to evaluate the efficacy of these nutraceutical products for TD prevention and inform strategies for Force Health Protection.
This release has been authorised by the directors of Immuron Limited.
| COMPANY CONTACT: Dr Jerry Kanellos, Ph.D. Chief Executive Officer Ph: +61 (0)3 9824 5254 info@immuron.com |
For more information visit: http://www.immuron.com
FAQ
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