Oramed Pharmaceuticals has concluded subject enrolment in a Phase II clinical trial of its oral insulin capsule, ORMD-0801, to treat non-alcoholic steatohepatitis (NASH). 

The company anticipates reporting topline data from the trial in the second half of this year.

ORMD-0801 is claimed to be the first oral insulin to be analysed to treat NASH.

The multicentre, double-blind trial is designed to assess the safety and potential efficacy of ORMD-0801 in NASH patients with Type 2 diabetes. 

Currently, trial centres in the US and Israel are evaluating ORMD-0801 in trial subjects.

Safety and percentage variation in liver fibrosis, liver fat content and liver steatosis from baseline as assessed through MRI-PDFF following 12 weeks of treatment are the efficacy endpoints of the trial.

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Oramed CEO Nadav Kidron said: “There is currently no drug approved to treat this disease, leaving NASH with a serious unmet medical need. 

“With direct action on the liver, we believe that ORMD-0801 has the potential to address over 50% of people with diabetes who also suffer from NASH, a population with unfortunately increased mortality. 

“We look forward to analysing and reporting topline data, which we expect will confirm our prior pilot study’s efficacy and safety results.”

A severe and progressive liver disease, NASH is caused by fat accumulation in the liver and accompanied by liver cell destruction, inflammation and liver scarring in certain cases. 

It could advance to cirrhosis, liver cancer, liver failure and even death over the course of time. 

At present, there exists no approved therapy for NASH, with patients left with very few therapy options.