Infectious diarrhea could soon be not so infectious with confirmation from biotech company Immuron (ASX: IMC) that the first patients have enrolled for their Phase 2 clinical trial seeking to address issues that arise from unpleasant episodes.
The trial is a response to the persistent challenge of infectious diarrhea among travellers and military personnel deployed overseas. Recognizing the need for effective preventative measures is collaborating with the US Naval Medical Research Command (NMRC) on the trial, with its officers often on the front line of the illness.
The clinical study, led by Principal Investigator Dr. Kawsar Talaat, MD, at the Johns Hopkins University (JHU) Center for Immunization Research (CIR) Inpatient Unit, and will focus on evaluating the efficacy of Immuron’s CampETEC product in preventing infectious diarrhea caused by Campylobacter and Enterotoxigenic Escherichia coli (ETEC).
The CampETEC product, designed specifically to protect against Campylobacter and ETEC infections, signifies an advancement in the pursuit of preventive treatments for Travelers’ diarrhea—a prevalent ailment affecting these high-risk groups.
Utilising a controlled human infection model (CHIM), the Phase 2 clinical trial aims to assess the safety and protective efficacy of the CampETEC product. The primary endpoint focuses on preventing or reducing moderate to severe diarrhea. The in-patient phase of the trial is expected to conclude by the end of December 2023, with the overall study slated for completion by June 2024.
Immuron is then hopeful it can report results from the trial in the second half of CY24.
Dr. Talaat emphasised the pressing need for alternatives to antibiotics for infectious diarrhea with overprescription having long-term impacts in resistance among enteric pathogens. Additionally, the medical community acknowledges the potential long-term consequences of traveller’s diarrhea, including post-infectious irritable bowel syndrome (IBS) and various autoimmune diseases.
The NMRC’s commitment to prioritising the clinical development of this study reflects the broader acknowledgment of the importance of preventing and mitigating the impact of infectious enteric diseases, particularly among military personnel where infection in isolated locations (such as a Navy Vessel) can have catastrophic effects on operations.
As the in-patient phase progresses, Immuron and its collaborators express optimism about the potential impact of the CampETEC product in providing a proactive defence against infectious diarrhea. The successful development of this prophylactic therapeutic has the potential to address better approaches to enteric infections, enhancing the quality of life and operational readiness of those at risk of infectious diarrhea.
For the financial year ended 30 June 2023, Immuron reported $1.8 million revenue, with a net loss after tax of $3.8 million attributed to the Company’s ongoing research and development expenditure.
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