Immuron announces fda removed clinical hold on new campylobacter etec therapeutic paves way for clinical trial initiation

Highlights: u.s. food and drug administration (fda) remove clinical hold on new campylobacter etec therapeutic ind application us naval medical research centre (nmrc) satisfactorily addressed all clinical hold issues identified by the fda ind to evaluate the efficacy of new campylobacter etec therapeutic in two human phase 2 clinical trials is now active one trial will focus on the ability of the hyperimmune product to prevent infectious diarrhoea caused by etec the second trial will focus on protecting volunteers against moderate to severe campylobacteriosis melbourne, australia, may 08, 2023 (globe newswire) -- immuron limited (asx: imc; nasdaq: imrn), an australian based and globally integrated biopharmaceutical company that has developed two commercially available oral immunotherapeutic products for the treatment of gut mediated diseases, is pleased to announce that the us naval medical research center (nmrc) has received approval from the us food and drug administration (fda) to proceed with the clinical evaluation of a new oral therapeutic targeting campylobacter and enterotoxigenic escherichia coli (etec) developed in collaboration with immuron. the fda has removed a clinical hold on the investigational new drug (ind) application allowing the nmrc to proceed with its plans to evaluate the efficacy of the hyperimmune product to prevent infectious diarrhoea caused by campylobacter and etec which is now active.
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