Australian-based biopharmaceutical company Immuron has closed enrolment in the Phase II clinical trial of its IMM-124E to treat non-alcoholic steatohepatitis (NASH) patients.
IMM-124E is developed to act against LPS antigens through its binding and neutralising activity.
The drug also consists of adjuvants that enhance regulatory T-cells to inhibit inflammation in target organs.
It is believed that the anti-LPS activity minimises the LPS challenge to the liver and down-regulates the T regulatory cell population in chronic inflammation and other metabolic defects associated with NASH.
The multi-centre, double blind, randomised Phase II trial will evaluate the safety and efficacy of IMM-124E when compared to placebo after six months of treatment.
Conducted in the US, Australia, and Israel, Immuron has enrolled a total of 120 randomised patients.
Immuron chief executive officer Thomas Liquard said: “This significant milestone is a result of the efforts of many over the past three years.
"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.”
It is estimated that the topline results of the Phase II trial will be reported in the second half of this year.
Immuron develops and commercialises oral immunotherapeutics for the treatment of many gut mediated diseases. The firm's safe technology platform is claimed to facilitate a shorter development therapeutic cycle.