Immuron (ASX: IMC) has received the all clear from the United States Food and Drug Administration to proceed with a Phase 2b clinical trial of its bovine colostrum-derived therapeutic, IMM-124E, for the treatment of Non-Alcoholic Steatohepatitis (NASH) and Fatty Liver.
Importantly, the company’s Investigational New Drug submission to begin the double-blind, placebo-controlled and dose ranging trial was cleared by the United States Food and Drug Administration without the authority raising any concerns.
The trial – which will be undertaken at sites in the United States, Australia and Israel – primarily aims to determine the safety and efficacy of Immuron’s orally administered IMM-124E in patients with biopsy-confirmed NASH.
IMM-124E has the potential to be the first available and approved treatment for NASH patients in the world and the only product candidate to date that addresses the pathogenesis of the disease, representing an extremely lucrative opportunity for Immuron.
Significantly, this market – worth US$4.4 billion (A$4.3 billion) in the U.S. alone – has no existing approved competitors, according to Immuron.
NASH is one of the most common liver diseases in the western world. It is associated with obesity, diabetes and hyperlipidaemia.
It affects approximately 5% of the lean population, 20% of the obese population and 50% of morbidly obese people.
It resembles alcoholic liver disease but occurs in people who drink little or no alcohol. The major feature in NASH is fat in the liver along with inflammation and damage.
NASH can be severe and can lead to cirrhosis, in which the liver is permanently damaged and scarred and no longer able to function properly.
Based on the data generated to date, IMM-124E has a high safety profile and is able to elicit a response in many fatty liver/NASH parameters including insulin resistance and elevated serum cholesterol.
Immuron revealed late last year it is also in early discussions with potential global licensees.