Australian-based biopharmaceutical company Immuron (ASX:IMC) reports it has submitted an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) for Travelan.
The company says the phase two clinical trial will evaluate the efficacy of a single dose regimen of Travelan in a controlled human infection model (CHIM) using the enterotoxigenic Escherichia coli (ETEC) strain H10407.
The clinical study aims to enrol up to 60 healthy adult subjects, and each will be randomly assigned to receive either a once-daily does of 1,200mg of Travelan or placebo.
Immuron reports it is the sponsor of the IND, and the clinical study will be conducted by the Contact Research Organisation Pharmaron CPC at its FDA inspected clinical research facility in Baltimore, Maryland in the USA.
Dr Mohamed Al-Ibrahim will be the Principal Investigator for the study and recruitment planned to commence in the first half of 2023 subject to FDaA approval with headline results from the clinical trial expected to be reported by the end of 2023.
Immuron reports 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 judgement, decreases morale and declines operational readiness.
The first line of treatment for infectious diarrhoea is the prescription of antibiotics. The company reports in the last decade, several enteric pathogens have an increasing resistance to commonly prescribed antibiotics.
In addition, travellers’ diarrhoea is now recognised by the medical community to result in post-infectious sequelae including post-infectious Irritable Bowel Syndrome and several post-infectious autoimmune diseases.
Travelan is an orally administered passive immunotherapy that prophylactically reduces the likelihood of contracting travellers’ diarrhoea.
Immuron is an Australian biopharmaceutical company focused on developing and commercialising orally delivered targeted polyclonal antibodies for the treatment of inflammatory mediated and infectious diseases.