Immuron Limited (NASDAQ: IMRN) has received $4.45 million in funding from the US Department of Defense (DoD) for a new research agreement.
Immuron receives research funding from DoD
The goal of this new agreement, dubbed “Biologics License Application (BLA) of a therapeutic Bovine Immunoglobulin supplement targeting Travelers’ Diarrhea caused by Enterotoxigenic Escherichia Coli (ETEC),” is to test and confirm the efficacy of a single large Travelan dose regimen in a controlled human infection model (CHIM) trial using the enterotoxigenic Escherichia coli (ETEC) strain This single, larger dose regimen may be better appropriate for military people.
The clinical research will enroll up to 60 participants randomly assigned to either a once per day 1200 mg of Travelan dose or a placebo. Because the inpatient hospital can accommodate up to 30 study participants at a time, the trial will be split into two groups). The anticipated clinical study’s findings will also be used to help determine the dose in the key third phase registration studies for BLA approval. A project launch meeting with the US government sponsors has been set for the end of January.
New research expands Immuron’s clinical development program
CEO Dr. Jerry Kanellos said, “This new project expands our clinical development program and represents the first of several significant clinical trials which the company expects to undertake with the US Military in 2022. 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, with one trial focusing on the ability of the hyperimmune product to protect volunteers against moderate to severe campylobacteriosis, and the second trial focusing on ETEC infections. The new funding is testament to the value proposition our hyperimmune bovine polyclonal colostrum technology offers to benefit the US Military as well as the civilian international traveling population.”
The proposed development plan is based on Travelan’s clinical and commercial trial experience. When challenged with ETEC, two company-sponsored clinical studies showed that Travelan provided 84 percent to over 90% protective effectiveness against severe diarrhea.