Immuron Limited (NASDAQ: IMRN) (ASX: IMC) is an Australia-based biopharmaceutical company with a focus on the research and development of oral immunotherapy polyclonal antibodies for the treatment and prevention of infectious and immune modulated diseases. U.S.-listed shares soared 726.62% through early trading on Tuesday, June 9, 2020. Over the past month, Immuron has seen an average daily volume of 20,960 shares. However, through Tuesday morning, already 41,264,239 shares have traded hands, equating to $716.35 million in dollar volume.
IMRN soared Tuesday morning after announcing their research collaborators, the U.S. DoD Naval Medical Research Center (NMRC), requested a pre-investigational new drug application (Pre-IND) meeting with the US Federal Drug Administration (FDA) for its new treatment of campylobacteriosis and ETEC infections. Previously the COVID-19 breakout had halted progress for research and development for their new treatment due to a shift in focus towards COVID-related treatments and therapeutics.
However, with the easing of restrictions, Immuron estimates it will receive the FDA’s comments from the Pre-IND report on Wednesday, June 10, 2020. The NMRC plans on filing an investigational new drug (IND) application later in 2020 and launching Phase 2 clinical studies during the first half of 2021.
Under the proposal submitted to the FDA, the research collaborators will seek to conduct two human Phase 2 clinical trials during early 2021. One clinical trial will focus on treatment of moderate-to-severe campylobacteriosis. The second clinical trials will be centered around the treatment of ETEC infections (E-Coli).
Dr. Jerry Kanellos, CEO of Immuron Ltd., commented, “We have been monitoring the situation closely and I am pleased to say that 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.”
Campylobacteriosis is the most common bacterial cause of diarrheal illness in the U.S., affecting 1.5 million Americans every year. ETEC is the name given to disease-causing E. coli which produce toxins in the intestine which causes diarrhea. ETEC infects 400 million people per year, which is 5.3% of the world’s population, and is responsible for 400,000 deaths annually.
Article By: Andrew Rego