on Jan 12, 2022
The study will happen across two cohorts.
The new project is set to expand the company’s clinical development program.
Immuron Limited (NASDAQ: IMRN) went up 30% after it announced that it had received $6.2 million from the Department of Defense to conduct clinical research on a dosing regimen for Travelan.
This new research agreement with the DoD aims to confirm and test the efficacy of dosing regimens of Travelan in a CHIM (controlled human infection model) clinical research study using the ETEC (enterotoxigenic Escherichia coli) strain H10407.
Details of the Study
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This singular dosing regimen is potentially more ideal for military use. Up to around sixty volunteers will take part in the study. The volunteers will be randomly assigned to get a placebo or a single dose of Travelan (1200 mg) daily. The study will happen across two cohorts, n=15 placebo subjects, and n=15 Travelan subjects.
The results the researchers get from this proposed study will also be beneficial in the Phase III registration clinical trial for the BLA licensure process.
This proposed development project is based on previous clinical and commercial trial experiences with Travelan. A pair of company-sponsored clinical research studies have shown that the drug conferred around 84% to more than 90% protective efficacy when treating severe to moderate diarrhea.
These clinical research studies were conducted a 200 mg and 400 mg dose of Travelan, which researchers administered thrice daily. However, ongoing talks with Navy and Army officials have shown that such dose regimens can prove cumbersome for military staff deployed in austere areas.
Military field studies have highlighted low compliance with products that require more than one dose per day.
Top management comments
Immuron’s Chief Executive Officer, Dr. Jerry Kanellos, claims that this new project will help expand their overall clinical development program. He says that it also represents the first of many significant clinical research studies which Immuron expects to conduct with the United States Military forces. Dr. Kanellos said:
The NMRC also plans to clinically evaluate the protective efficacy of our new oral therapeutic targeting Campylobacter and ETEC this year in two controlled human infection-model clinical trials.
He continued and said that one trial will concentrate on the product’s ability to protect the volunteers against severe to moderate campylobacteriosis.