NMRC Requests Meeting with FDA for Guidance on two Phase 2 trial

NASDAQ:IMRN   Immuron Limited
US DoD Naval Medical Research Center Requests Meeting with FDA for Guidance on two Phase 2 trials to Prevent Acute Infectious Diarrhea

Key Points

NMRC requests Pre-IND meeting with FDA on the development of a new oral therapeutic targeting Campylobacter and ETEC
Two human phase II clinical trials to be conducted in 2021
One trial will focus on the ability of the hyperimmune product to protect volunteers against moderate to severe campylobacteriosis
The second trial will focus on ETEC infections

“We received a formal start work notification and approval at the end of January 2020 from the Henry Jackson Foundation for the Advancement of Military Medicine to commence work on the sub award,” said Dr . Jerry Kanellos, CEO of Immuron Ltd.

Immuron currently markets two products: Protectyn, a formulation of hyperimmune bovine colostrum designed to remove harmful bacteria and their toxins from the gut, and Travelan, an over-the-counter immune supplement to reduce the risk of diarrhea and reduce symptoms of minor GI disorders.

Immuron, which focuses on developing and commercializing oral immunotherapeutics for the prevention and treatment of gut mediated pathogens, said it has reached a funding agreement with the U.S. Naval Medical Research Center, or NMRC, to develop a combined Campylobacter and enterotoxigenic E. coli-specific anti-microbial preventative for clinical evaluation.

The Department of Defense has approved a $3.7 million funding for the purpose.

The agreement provides for Immuron and NMRC collaborating on manufacturing and evaluating the new product that offers protection against travelers' diarrhea caused by Campylobacter and ETEC pathogens.

What Next: Immuron said the collaboration will evaluate protective efficacy of the new product using two controlled human infection-model clinical trials, with one focusing on campylobacteriosis, and the second trial on ETEC infections.