Immuron (ASX:IMC), an Australian company focused on developing and commercialising oral immunotherapeutic products for the prevention and treatment of gut pathogens, has announced the restart of its clinical development program.
The company halted the program during the COVID-19 pandemic.
The US Naval Medical Research Centre has (NMRC) has reported that most of the inpatient clinical trial sites in the US are coming off COVID-19 based restrictions.
Immuron says it looks forward to the recommencement of the planned NMRC clinical development programs. I
The manufacturing campaign for the new drug product targeting Campylobacter and Enterotoxigenic Escherichia coli (ETEC) was completed in October 2021.
The company said the investigational medical products will be transferred to the Johns Hopkins Bloomberg School of Public Health in the US. This is the clinical trial site to be used to conduct the two planned clinical studies.
The safety and protective efficacy of the product will be tested utilising two controlled human infection-model clinical trials. One trial will focus on the ability of the hyperimmune product to protect volunteers against ETEC infections and the second on moderate to severe campylobacteriosis.
A total of 60 volunteers divided into two inpatient cohorts will be enrolled in the studies and randomly assigned to either Cohort 1 ETEC or Cohort 2 C.jejuni controlled human infection models.
Immuron said NMRC is also working on the Investigational New Drug application and the clinical protocols. The NMRC plans to file the IND application with the US FDA early next year.