Second Genome has dosed the first patient in a Phase II clinical trial assessing SGM-1019 for the treatment of nonalcoholic steatohepatitis (NASH), a subtype of nonalcoholic fatty liver disease (NAFLD).
SGM-1019 is an oral, small molecule inhibitor of the P2X7 receptor that can activate inflammasome, and mediate inflammation and fibrosis.
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The company intends to enrol 100 patients at sites across the US for the randomised, double-blind, placebo-controlled trial.
The trial aims to investigate the preliminary safety, tolerability, pharmacokinetics, and efficacy of twice-daily dosing of oral SGM-1019 at two different dose levels.
It is expected to provide top-line data in the first half of next year.
The trial’s principal investigator Stephen Harrison said: “There are no approved therapies for NASH at this time, and, while there are many in development, SGM-1019 is directed at the inflammation underlying this condition.
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By GlobalData“We know that inhibiting P2X7 results in significant reduction in inflammation and fibrosis in preclinical models of disease and look forward to seeing the data from this study.
“SGM-1019 has the potential to provide a much-needed treatment option for the growing number of patients with NASH.”
The National Institute of Diabetes and Digestive and Kidney Diseases suggests around 3% to 12% of the US population is affected by NASH.
The disease commonly attacks obese people or those who have other metabolic conditions, including type 2 diabetes or elevated lipids.
