No Comments Biopharma company Immuron (IMC) has received U.S. Food and Drug Administration (FDA) guidance for a new investigational drug designed to treat diarrhoea.
The drug is being developed to treat campylobacteriosis and Enterotoxigenic Escherichia coli (ETEC) infections — both dominant causes of Travelers’ Diarrhoea.
Research partner Naval Medical Research Centre (NMRC) met with the FDA on behalf of Immuron to discuss the chemistry, manufacturing, and controls of the new drug, as well as the proposed testing specifications of the product. On top of this, the two parties outlined planned clinical studies to test the drug’s safety and effectiveness.
Immuron CEO Dr Jerry Kanellos said the FDA discussions for the new product are an important milestone when developing any new drug for therapeutic evaluation.
“The information obtained from this review will assist in the development of the Investigational New Drug application and provides a clear roadmap forward for conducting the two planned clinical studies next year,” Dr Jerry said.
“The company is also pleased to inform shareholders that the manufacturing program is proceeding as planned,” he added.
“We have completed the second immunisation campaign and are on schedule to harvest the Hyper-immune colostrum in September this year which will be used to manufacture the drug product that will be used to treat moderate to severe campylobacteriosis and ETEC infections,” he said.
The company currently sells Travelan, which is designed to reduce the likelihood of contracting Travelers’ Diarrhoea. The product is licenced by the TGA in Australia, as a national health product in Canada, and as a dietary supplement in the U.S.
Though the company’s new drug is still in the early stages of development, shareholders seemed impressed by the FDA discussions highlighted today. Immuron shares closed 11.36 per cent higher at 24 cents each. The company has a $43.68 million market cap.