Immuron provides update on research collaboration with NMRC

Immuron is pleased to provide shareholders with an update on the company's research collaboration with the Naval Medical Research Center to develop and clinically evaluate a new therapeutic against campylobacter and ETEC. The NMRC recently requested a Pre-IND meeting with the U.S. 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 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 application later this year and commence the Phase 2 clinical studies during the first half of 2021.