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

MELBOURNE, Australia, June 09, 2020 (GLOBE NEWSWIRE) — Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian biopharmaceutical company focused on developing and commercializing oral immunotherapeutics for the prevention and treatment of gut mediated pathogens, today is pleased to provide shareholders with an update on the company’s research collaboration with the Naval Medical Research Center (NMRC) to develop and clinically evaluate a new therapeutic against campylobacter and ETEC (E-Coli). The NMRC recently requested a Pre-IND meeting with the U.S. Food and Drug administration (FDA) regarding its new investigational drug which the company is developing to treat moderate to severe campylobacteriosis and ETEC infections.

The FDA on the 26 May 2020 issued guidance explaining how the coronavirus disease public health emergency is impacting the conduct of formal meetings and its review of certain user fee-funded applications. The FDA will focus its resources on applications and submissions related to COVID-19 and other life-threatening conditions. The FDA will still aim to conduct initial investigational new drug application (IND) 30-day safety reviews and respond to “other important safety issues that may emerge during IND development”. The agency will provide written comments on the non-clinical information in the Pre-IND information package which is planned to be submitted on the 10th of June 2020. Following the FDA’s guidance and feedback, the NMRC plans to file an investigational new drug (IND) application later this year and commence the Phase 2 clinical studies during the first half of 2021.

“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.

“The Australian Importation permit required to ship the vaccines from the NMRC was approved by Biosecurity Australia and the NMRC vaccines were shipped to our contract research partner to commence the project. The COVID-19 pandemic put the brakes on this and all our research and development activities. We have been monitoring the situation closely and I am please to say with the easing of restrictions around Australia work on the development of the clinical product can now recommence. The plan is to have the product completed by the end of this year and have it ready for clinical evaluation next year.”

The COVID-19 pandemic has also impacted the IMM-124E pediatric clinical study in Nonalcoholic Fatty Liver Disease. The study’s Principle Investigator Dr. Miriam Vos from the Emory University School of Medicine closed the study earlier this year with only 22 subjects out of a target 40 completing treatment as specified in the study protocol. The study findings were reported as negative which was not unexpected given the small sample set used in the analysis and there was no substantial changes in ALT (Primary study end point) in the active arm of the study when compared to placebo.

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