- Immuron (IMC) says its clinical development programs are back on track following COVID-19 delays
- After facing a more than 12-month hiatus, the US Naval Medical Research Centre (NMRC) reported most inpatient clinical trial sites in the US removed restrictions
- The NMRC says it plans to file an investigational new drug application with the US FDA early in 2022, with the first of the trials scheduled to begin in the first half of the calendar year
- Immuron shares are up 4 per cent, trading at 12.5 cents at 4:55 pm AEDT
Immuron (IMC) said its clinical development programs are back on track following COVID-19 delays.
Immuron’s focus has been on developing and commercialising oral immunotherapeutic products for the prevention and treatment of gut pathogens, particularly Travelan. Travelan is an orally administered immunotherapy that reduces the likelihood of contracting travellers’ diarrhea.
The company has been working to manufacture investigational medical products like Travelan to support the US Naval Medical Research Centre (NMRC) clinical programs.
After facing a more than 12-month hiatus due to the COVID-19 pandemic, the NMRC reported most inpatient clinical trial sites in the US had removed restrictions, with the company looking to recommence development programs.
The medical products under investigation are due to be transferred to the Johns Hopkins Bloomberg School of Public Health in the US, which will become a clinical trial site for two planned studies.
The product will be tested on 60 volunteers, with one trial focusing on the ability of the hyperimmune product to protect volunteers against ETEC infections, and the second looking at moderate to severe campylobacteriosis.
The update follows a manufacturing campaign for the new drug product targeting Campylobacter and Enterotoxigenic Escherichia coli (ETEC), which was completed in October 2021.
Meanwhile, the NMRC said it plans to file an investigational new drug application with the US Food and Drug Administration early in 2022, with the first of the trials scheduled to begin in the first half of the calendar year.
Immuron shares were up 4 per cent, trading at 12.5 cents at 4:55 pm AEDT.