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

Rhea-AI Summary

Immuron Limited (ASX: IMC; NASDAQ: IMRN) has announced a collaboration with the Naval Medical Research Center (NMRC) focused on developing a new oral therapeutic targeting Campylobacter and ETEC infections. A Pre-IND meeting with the FDA has been requested, paving the way for Phase II clinical trials in 2021. The trials aim to evaluate the efficacy of the therapeutic in protecting against severe campylobacteriosis and ETEC infections. However, previous study results indicated negative findings in the IMM-124E pediatric trial for Nonalcoholic Fatty Liver Disease due to a small sample size.

Positive

• Collaboration with NMRC to develop new therapeutic for Campylobacter and ETEC.
• Request for Pre-IND meeting with FDA indicates progress in drug development.
• Planned Phase II clinical trials for 2021 show commitment to advancing product testing.

Negative

• Previous IMM-124E pediatric study in Nonalcoholic Fatty Liver Disease reported negative findings.
• Only 22 out of 40 subjects completed treatment in the pediatric study.

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.

COMPANY CONTACT:

Dr Jerry Kanellos, Ph.D.
Chief Executive Officer
Ph: +61 (0)3 9824 5254
info@immuron.com

For more information visit: http://www.immuron.com

FAQ

What is the purpose of Immuron's upcoming clinical trials in 2021?

The trials are designed to evaluate the efficacy of a new oral therapeutic against moderate to severe Campylobacter and ETEC infections.

When was the Pre-IND meeting with the FDA requested?

The Pre-IND meeting was requested by NMRC in June 2020.

What were the results of the IMM-124E pediatric study?

The IMM-124E pediatric study reported negative findings, with no significant changes observed in ALT levels.

What are the next steps after the Pre-IND meeting for Immuron?

Following the Pre-IND meeting, NMRC plans to file an IND application and commence Phase II clinical studies in 2021.

How has COVID-19 impacted Immuron's research activities?

COVID-19 caused delays in research activities and the IMM-124E study, resulting in a reduced number of subjects completing treatment.