Immuron (ASX:IMC) has successfully manufactured trial supplies of its clinical candidate IMM-529, an oral immunotherapeutic targeting the prevention of clostridium difficile Infection (CDI).
CDI results from disruption of normal, healthy bacteria in the colon, often as a result of antibiotics.
IMM-529 is a biological product which is intended to prevent and treat CDI without destroying the microbiome like antibiotic treatments, allowing the microbiome to return to a healthy state.
The antibodies survive transit through the stomach and remain functional in the large intestine.
IMM-529 was manufactured by the Commonwealth Scientific and Industrial Research Organisation (CSIRO) Separations Science team and Pharmaceutical Packaging Professionals.
Human safety and efficacy studies (Phase 1/2 clinical trial) of IMM-529 will start by the end of Q2 2017, and will aim to build on positive pre-clinical results.
These results were reported from a series of proof-of-concept efficacy studies completed by Dr. Dena Lyras and her research team at the Monash University in Melbourne.
CDI has become a major-medical problem causing an estimated annual economic cost of more than US$10 billion globally.
The problem is especially acute in hospitals and in long-term in-patient care facilities.
An estimated 29,000 patients die each year from CDI in the U.S. alone. Recurrent CDI affects circa 100,000 people in the U.S. annually.
Immuron’s share price has more than doubled since the start of 2017, last trading at $0.55.