Immuron to Proceed with Clinical Trials as FDA Removes Hold on Campylobacter Therapeutic
Immuron Limited (Nasdaq: IMRN) will evaluate the efficacy of new Campylobacter ETEC Therapeutic in two human Phase 2 clinical trials following the FDA removing a clinical hold on the company’s IND application.
The new oral therapeutic targeting Campylobacter and Enterotoxigenic E. coli (ETEC) is being developed in collaboration between the US Naval Medical Research Center (NMRC) and Immuron.
The company’s stock hit a 52-week high at $2.71 following the news.
The safety and protective efficacy of the product will be tested via 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 trial will focus on moderate to severe campylobacteriosis.
A total of 60 volunteers divided into two inpatient cohorts will be enrolled in the randomized, placebo-controlled trials and randomly assigned to either Cohort 1 ETEC or Cohort 2 jejuni controlled human infection models.
The first clinical study will be conducted at the Johns Hopkins University (JHU) Center for Immunization Research (CIR), and commencement is subject to ethics approval from the Institutional Review Board.Infectious diarrhea is the most common illness reported by travelers visiting developing countries and among US troops deployed overseas.
A preventative treatment that protects against enteric diseases is a high priority objective for the US Military.
Immuron Limited (ASX: IMC, NASDAQ: IMRN), is an Australian biopharmaceutical company developing and commercializing orally delivered targeted polyclonal antibodies for the treatment of infectious diseases.