- Oops!Something went wrong.Please try again later.
US Naval Medical Research Centre (NMRC) submits IND application to the U.S. Food and Drug administration (FDA)
Two human phase II clinical trials to be conducted.
One trial will focus on the ability of the hyperimmune product to prevent infectious diarrhea caused by ETEC and scheduled to be initiated in July 2022.
The second trial will focus on protecting volunteers against moderate to severe campylobacteriosis.
MELBOURNE, Australia, May 11, 2022 (GLOBE NEWSWIRE) -- Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian biopharmaceutical company focused on developing and commercializing oral immunotherapeutic products for the prevention and treatment of gut pathogens, today is pleased to announce that the US Naval Medical Research Center (NMRC) has submitted an Investigational New Drug (IND) application to the US Food and Drug Administration for a new oral therapeutic targeting Campylobacter and ETEC developed in collaboration with Immuron.
NMRC is preparing to commence the first of two planned clinical trials in the United States following approval of the application. The safety and protective efficacy of the product will be tested utilizing two controlled human infection-model clinical trials, with one trial focusing on the ability of the hyperimmune product to protect volunteers against ETEC infections, and the second trial focusing 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.
Infectious diarrhea is the most common illness reported by travelers visiting developing countries and amongst US troops deployed overseas. The morbidity and associated discomfort stemming from diarrhea decreases daily performance, affects judgment, decreases morale, and declines operational readiness. The first line of treatment for infectious diarrhea is the prescription of antibiotics. Unfortunately, in the last decade, several enteric pathogens have an increasing resistance to commonly prescribed antibiotics. In addition, travelers' diarrhea is now recognized by the medical community to result in post-infectious sequelae, including post-infectious irritable bowel syndrome and several post-infectious autoimmune diseases. The development of an oral immunotherapy preventative treatment that protects against endemic diarrheal diseases, is a high priority objective for the US Military.
This release has been authorised by the directors of Immuron Limited.
For more information visit: http://www.immuron.com