IMRN - Immuron responds to FDA clinical hold on proposed trials of antibacterial drug

• Immuron ( NASDAQ: IMRN ) said it submitted a response to the U.S. Food and Drug Administration (FDA) related to the clinical hold placed by the agency on the start of trials of an oral antibacterial drug.
• The FDA had notified the company and the US Naval Medical Research Center (NMRC) in July 2022 of insufficient information in the investigational new drug (IND) application for a new oral therapeutic targeting Campylobacter and ETEC.
• Immuron said on Wednesday that the FDA provided guidance to the NMRC after a meeting in December 2022. Following this, NMRC, Johns Hopkins University (JHU) and Immuron have now addressed the specific concerns of the FDA clinical hold and submitted the response letter.
• The Australian company noted that the FDA will provide feedback on the clinical hold in 30 calendar days from receipt of the NMRC information package.
• Campylobacter is an infection causing diarrhea due to the Campylobacter bacteria. Meanwhile, Enterotoxigenic Escherichia coli (E. coli), or ETEC, is also an important cause of bacterial diarrheal illness, as per the CDC .

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