Liver inflammation reduced in NASH patients

Biopharmaceutical company Immuron (ASX:IMC) has announced a new treatment for LPS-related inflammation, based around its development drug IMM-124E. The discovery was made during IMM-124E Phase II trials for non-alcoholic steatohepatitis (NASH) treatment.

NASH is the most extreme form of non-alcoholic fatty liver disease, occurring when fat is deposited in the liver due to causes other than excessive alcohol use. Meanwhile, lipopolysaccharide (LPS) is a common bacterial toxin that causes damage to the liver and other parts of the body — and is a known mediator of liver inflammation in patients with NASH.

A total of 133 NASH patients were enrolled in the study and were treated with either IMM-124E or placebo for six months. IMM-124E was found to demonstrate excellent safety and tolerability, statistically significant reduction in LPS levels and serum ALT (alanine transaminase), with at least 30% reduction in serum ALT compared to placebo. Additional biomarkers associated with NASH and liver damage were also reduced, including aspartate transaminase (AST) and cytokeratin-18 (CK-18). And with the drug shown to stay safely within the GI tract, side effects were minimal.

“The IMM-124E drug candidate has been developed to target LPS in the gut and prevent it translocating into the portal circulation,” said Professor Arun Sanyal from Virginia Commonwealth University, principal investigator on the study. “The study results clearly demonstrate a statistically significant reduction of serum LPS levels in the treatment groups when compared to placebo and provides us with a proof of concept that metabolic endotoxemia can indeed be decreased using this drug candidate.

“We are encouraged that IMM-124E, a drug with an exceptional safety profile, can lower the LPS-associated inflammatory burden and improve liver enzymes. The clinical applications for this drug candidate are numerous and very exciting indeed.”

Considering the association of elevated serum LPS in the development and progression of NASH, Immuron believes the outcome of the trial is an important milestone towards commercialisation of IMM-124E.

“The proof for IMM-124E’s non-absorbable nature and excellent safety profile, as reported, will allow us to conduct further clinical research aimed at maximising the effect with potentially higher doses and longer treatment times,” said Dr Dan Peres, senior vice president head of medical at Immuron. “Furthermore, these results support that IMM-124E offers potential as a standalone treatment or in combination with other classes of drugs.”

Immuron CEO Dr Jerry Kanellos added that there is growing literature implicating LPS in many chronic illnesses, including Alzheimer’s, diabetes, obesity, cardiovascular disease, chronic fatigue syndrome, cancer, inflammatory bowel disease, depression and schizophrenia. There is thus the potential for IMM-124E to be used in the future to treat a broad range of diseases.

The news was followed five days later with the announcement that Immuron has finalised a private placement capital raising with a large US institutional investment fund, the terms of which will raise the company approximately $5.1 million (before costs of the offer) for the issuance of 13,162,744 new ASX shares at $0.39 per share, plus three new free-attaching options for every new share issued.

Immuron expects this capital raise to secure the future funding needs of its other ongoing clinical programs, support marketing initiatives surrounding the company’s flagship product, Travelan, and provide ongoing working capital.

“Immuron has received a number of recent offers for financial support following the release of the company’s positive top-line results of its IMM-124E Phase II Non-Alcoholic Steatohepatitis (NASH) clinical study,” said Kanellos. “We’re very pleased that we have been able to partner with this large US institutional investor for this raising, and for them to take such a significant position in our company brings stability and validation to the company’s share register.”

Immuron (ASX:IMC) shares ended a whopping 64.91% higher at $0.47 on 8 March, the day the study results were released. They dropped back over the next four days, only to finish 20.51% higher, back at $0.47, when the capital raising was finalised on 13 March. They have since dropped back to $0.445 as of around 11 am (AEDT) on 14 March.

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