Immuron completes trial recruitment

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Immuron (ASX IMC) has announced its IMM-124E Phase 2 clinical trial for the treatment of NASH (Non-Alcoholic Steatohepatitis) has successfully reached its full recruitment milestone of 120 randomised patients.

Immuron is focused on oral immunotherapy utilising polyclonal antibody products to target immune-mediated diseases.

The Phase 2, multi-centre, double-blind randomised clinical study is designed to assess the safety and effectiveness of IMM-124E for the treatment of NASH.

According to the company, the effectiveness element is primarily focused on evaluating the effect of IMM-124E on patients with NASH, compared to placebo, after six months of treatment.

The clinical trial protocol was developed by Immuron in partnership with its Scientific Advisory Board led by Dr Arun Sanyal of Virginia Commonwealth University in the US. The study is being conducted in the US, Australia and Israel.

Immuron said it expects to report the trial's topline results in the second half of 2017.

NASH, a severe form of non-alcoholic fatty liver disease (NAFLD) that causes liver inflammation and damage, afflicts approximately 16 million people in the US each year.

There is currently no FDA approved treatment for NASH, meaning physicians tend to treat the disease by addressing underlying conditions such as diet and obesity.

“This significant milestone results from the efforts of many over the past three years," said Immuron CEO Mr Thomas Liquard. "I would like to communicate my profound gratitude to Immuron’s clinical team for their tireless effort, and also to our valued principal investigators and their teams, for their dedication to the IMM-124E clinical trial. IMM-124E has a unique multifactorial mechanism of action (MOA) that we believe possesses a unique combination of safety and efficacy attributes which have the potential to greatly improve outcomes for NASH patients worldwide.”

Dr Dan Peres, Immuron’s Head of Medical, said: “We are thrilled that Immuron's clinical team, in partnership with the investigators and site staff, have been able to significantly improve the study’s recruitment rate over the past few months to now reach full recruitment. I would like to especially thank our Lead Principal Investigator, Dr. Arun Sanyal, for his leadership throughout the trial. We look forward to continuing our clinical work with Dr. Sanyal and other site principal investigators through the completion of the trial and beyond.”