Immuron Ltd (NASDAQ:IMRN, ASX:IMC), an immunotherapy-focused biopharmaceutical company based in Australia, is readying to proceed with clinical evaluation of a new oral therapeutic targeting Campylobacter and Enterotoxigenic Escherichia coli (ETEC) following approval from the US Food and Drug Administration (FDA).
Approval comes after Immuron’s partner, the US Naval Medical Research Centre (NMRC), addressed all clinical hold issues identified by the FDA, allowing trials to proceed.
Immuron and the NMRC will evaluate the new Campylobacter ETEC Therapeutic under an investigational new drug (IND) application, in two human Phase 1 clinical trials, which are now active.
Clinical trial design
IMC intend to run two controlled human infection-model clinical trials, with one trial focusing on the ability of the hyperimmune product to protect volunteers against ETEC infections, and the second trial focusing on moderate to severe campylobacteriosis.
The company will divide 60 volunteers into two inpatient cohorts in the randomised, placebo-controlled trials and randomly assigned to either Cohort 1 ETEC or Cohort 2 C. jejuni controlled human infection models.
ETEC and C. jejuni are major causes of diarrhea, affecting between 30-70% of travellers depending on destination and season.
Infectious diarrhoea is the most common illness reported by travellers visiting developing countries and among US troops deployed overseas.
The morbidity and associated discomfort stemming from diarrhoea decreases daily performance, affects judgment, decreases morale and declines operational readiness.
The first line of treatment for infectious diarrhoea is the prescription of antibiotics, however several pathogens have developed increasing resistance to antibiotics.
The medical community also recognises several potential complications from traveller’s diarrhoea, including post-infectious sequelae, including post-infectious irritable bowel syndrome (IBS) and several post-infectious autoimmune diseases.
Immuron says a preventative treatment is a high priority for the US military.