Immuron To Pursue Clinical Development Through FDA For IMM-124E As TD Drug

  • Apr 11, 2019 AEST
  • Team Kalkine
Immuron To Pursue Clinical Development Through FDA For IMM-124E As TD Drug

Immuron Limited (ASX: IMC) is a biopharmaceutical sector company with operations in Australia. The group is also engaged in the commercialization and development of oral immunoglobulin therapeutics for the treatment of gut mediated diseases.

The company today, on 11th April 2019, announced plans to pursue clinical development of IMM-124E, a bovine polyclonal antibody drug candidate, formally through FDA registration pathway as a drug to prevent travelers’ diarrhea (TD).

With the intent of preventing travelers’ diarrhea in Australia, Travelan® is currently being marketed and sold as a listed medicine of Therapeutic Goods Administration by IMC, however, it is also being marketed for digestive tract protection in the U.S. and Canada as a dietary supplement and a natural health product.

30% to 60% of over 1 billion international travelers every year are affected by traveler’s diarrhea, and the symptoms of nausea, vomiting, fever, stomach cramps and diarrhea can continue for seven days. In clinical studies conducted, Travelan® proved to be an effective preventative against traveler’s diarrhea when taken as instructed.

Dr. Gary S. Jacob, the CEO of the company, mentioned that this is an important initiative by the company, which is strategic in nature and might increase the commercialization of the Travelan®/IMM-124E franchise. He further added that It is important to mark that Travelan® and IMM-124E drug candidates currently in the clinical development stage for gut mediated diseases are one and the same.

IMC is expecting FDA registration for IMM-124E as a drug for the prevention of travelers’ diarrhea and believes that the medicine has a strong potential for substantial sales benefits to them. The company is working aggressively for developing IMM-124E through the FDA, as it is planning to file an Investigational New Drug application and pursuing with FDA a rapid path for its clinical development.

The company forecasted its peak annual sales to be more than US$100 million annually for IMM-124E as an FDA approved drug, which can prevent travelers’ diarrhea. Completion of a recent trial on IMM-124E leads to a path of the medicine being evaluated in ongoing clinical trials in alcoholic steatohepatitis and pediatric non-alcoholic fatty liver disease.

Now let us quickly have a look at the performance of the stock of Immuron Limited and the returns it has produced over the past few months. The stock is currently trading at $0.190, decreased by ~2.56% during the day's trade, with a market capitalisation of $27.93 million (on 11 April 2019 AEST 3:20 PM). The stock opened the day at $0.195 and touched a day’s low price at $0.185; however, it touched a day high of $0.200. It has a 52-week high price of $0.400 and a 52-week low price of $0.170, with an average trading volume of 80,834. The company has generated a negative YTD return of 14.29% and has generated negative yields of 38.98%, 26.53% and 21.74% during the last six months, three months and one-month period, respectively.


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