Immuron completes manufacturing trial supplies of IMM-529
Microbiome pharmaceutical group, Immuron (ASX: IMC) has successfully completed manufacturing trial supplies of its clinical drug product candidate IMM-529, a first in class oral immunotherapeutic targeting the prevention of Clostridium difficile infection (CDI) recurrence.
The drug was manufactured by the CSIRO Separations Science team and Pharmaceutical Packaging Professionals, partly funded by a grant of $50,000 from the Food Innovation Australia Ltd (FIAL) Enterprise Solutions Centre Program.
Commenting on this development, IMC’s Chief Executive, Thomas Liquard said, “IMM-529 is the second therapeutic drug candidate the company is progressing towards clinical trials, and this demonstrates that Immuron’s platform has the potential to develop multiple therapeutics which may result in several revenue opportunities for the company in the future.”
The market responded positively to the news with the company’s shares rallying 7.5% to an intraday high of 57.5 cents.
Although, it should be noted that share trading patterns should not be used as the basis for an investment as they may or may not be replicated. Those considering this stock should seek independent financial advice.
Discussing upcoming milestones, management said that human safety and efficacy studies of IMM-529 were expected to start by the end of the second quarter of 2017 and would be building on the positive pre-clinical results reported from a series of proof of concept efficacy studies completed by the Monash University in Melbourne. The outcomes of these results should be available in mid-2018.
IMM-529 is a biological product which is intended to prevent and treat CDI without destroying the microbiome, as is the case with antibiotic treatments, thus allowing the microbiome to return to a healthy state. The antibodies survive transit through the stomach and remain functional in the large intestine.
The planned Phase I/II clinical trials of IMM-529 will evaluate the safety and efficacy of the immunotherapy in combination with existing standards of care in 60 patients with acute and chronic CDI, a major medical problem causing an estimated annual economic cost of more than US$10 billion globally.
The condition is especially acute in hospitals and in long-term in patient care facilities with an estimated 29,000 patients dying each year in the US alone from the gut disease.
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