IMRN - Immuron surges ~65% as FDA lifts hold to start trial of bacterial diarrhea drug
2023-05-08 06:42:05 ET
- Immuron ( NASDAQ: IMRN ) said the U.S. Food and Drug Administration (FDA) removed a clinical hold on the start of trials of an oral antibacterial drug for preventing infectious diarrhea.
- The Australian company noted that the FDA lifted the clinical hold on an investigational new drug (IND) application allowing the U.S. Naval Medical Research Center (NMRC) to proceed with trials of the oral therapy — developed with Immuron — for preventing infectious diarrhea caused by Campylobacter and Enterotoxigenic Escherichia coli (ETEC).
- NMRC satisfactorily addressed all clinical hold issues identified by the FDA, and the IND for two phase 2 trial for the drug was now active, according to Immuron.
- The IND filing had been put on hold by the FDA in July 2022 citing insufficient information. The two parties then submitted a response to the the FDA in January this year.
- Immuron said on Monday that one trial will focus on the ability of the hyperimmune product to protect people against ETEC infections, and the second study will focus on moderate to severe campylobacteriosis.
- IMRN +64.71% to $3.08 premarket May 8
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Immuron surges ~65% as FDA lifts hold to start trial of bacterial diarrhea drug